Senior Quality Engineer Resume Samples

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F Hauck

Floy

Hauck

10985 Rodriguez Pass

New York

+1 (555) 472 6348

10985 Rodriguez Pass

New York

Phone

p +1 (555) 472 6348

Experience Experience

Boston, MA

Senior Quality Engineer

Boston, MA

Champlin-Krajcik

Boston, MA

Senior Quality Engineer

Create and define automation framework. Lead, develop and execute automation scripts using UFT, Selenium or other tools for online and mobile solutions
Manage and develop metrics and prepare trend reports related to Value Stream performance performance
Collects and analyzes data, develops quality reports and provides management the necessary information to make data-driven decisions
Provide guidance in assuring product specification development; test method development; and risk management for the Coseal and Floseal product lines
Execute/Manage Test Method and (Lab) Test Equipment lifecycle management (including development, validation & transfer)
Provide support to the MEMS and AISC development teams for new product design, change management and problem prevention/resolution
Assist in the development and improvement of the Product Excellence Management System

Philadelphia, PA

Senior Quality Engineer, Design Control

Philadelphia, PA

Waelchi-Lockman

Philadelphia, PA

Senior Quality Engineer, Design Control

Applies quality concepts and tools including basic statistics to create and/or, interpret information and data as related to inspection, testing and validation
Works across functions with various internal and external customers to manage diverse quality issues
Provides direction and support for the development and implementation of robust Quality Systems across regulated sites
Collaborates with design team to help facilitate the successful development and transfer of new products
Provides technical support to design team in generating risk files for new products
Conducts advanced data analyses to determine quality problems and identify larger scale quality improvements
Provides quality specific training and guidance to the organization to correctly identify and define quality problems early

present

San Francisco, CA

Senior Quality Engineer / Ems Co Ordinator

San Francisco, CA

McGlynn Inc

present

San Francisco, CA

Senior Quality Engineer / Ems Co Ordinator

present

Maintain good working practices and housekeeping
Formal engineering, quality, materials or metallurgical qualification
Ensuring all equipment, gauges, schedules, SAC, periodic checks, pressure rise tests etc are all up to date
Creating TDC/ build sheets/ loading plans
Logging and investigating internal non conformances
Ensuring supplier questionnaires are sent to new suppliers
Site environmental co-ordinator

Education Education

Bachelor’s Degree in Engineering

The University of Alabama

Bachelor’s Degree in Engineering

Skills Skills

Ability to develop strong domain knowledge to enable making product level decisions
Should have very good knowledge and strong experience in Software Testing & Quality Assurance
Knowledge of ISO/TS 16949 quality systems, quality control procedures, and basic metrology
ASQ Certified Quality Engineer, Certified Reliability Engineer or Black Belt and demonstrated ability to apply the specific Body of Knowledge
Ability to learn quickly and thoroughly while still able to adapt quickly to change
Basic Knowledge of industry standard quality tools and processes
Strong knowledge of FDA Quality System Regulation (QSR) with an emphasis on Process Validation and Design Controls; ISO 13485; and ISO14971
Good interpersonal skills and team work spirits. Ability to work a diverse team of Operations, Engineering & Quality teams and with suppliers
Excellent verbal and written communication skills and strong ability to document test results
Ability to lead team members and transfer knowledge of CtQ and other Quality tools and techniques

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15 Senior Quality Engineer resume templates

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Senior Quality Engineer Resume Examples & Samples

Ability to perform all functions of Software Quality Assurance Engineer and
Reviews test plans, test suites and cases and provides feedback to the junior team members
Insures the project’s deliverables and activities comply with requirements and QA Standards
Fielding questions regarding quality issues and assists in root cause analysis
Develops defect tracking standards and procedures specific to the Project
Provide mentorship to other team members
Assists with quality assurance training of internal staff. Provide training on the testing process and deliverables
Establishes testing metrics as required by the QA Standards. Gathers, analyzes and documents quality statistics in order to determine trends and high risk areas
Documents deviations from the established procedures and standards. Ensures that corrective action is taken for deviations from established standards
Identifies and coordinates data and configuration requirements for testing
Meet testing milestones in a fast/continuous delivery environment

Senior Quality Engineer Resume Examples & Samples

Write and maintain automated test
Identify and define test strategy
Creating, Reviewing and execution of high quality test plans
Identifying, Logging, tracking & Escalating defects in various stages
Maintain and own test environments
3+ years hands on QA/Testing Experience
Writing automated tests
Experience writing & implementing Gherkin style BDD tests using cucumber
Strong demonstrable Java coding and debugging skills
Experience with setting up and maintaining an automated test environment
Experience with programming/scripting languages (e.g., Java, Perl, Python, UNIX shell)
Performance testing (Gatling, J Meter)
Agile process experience
Experience with REST or SOAP Web Services and JSON and XML
Experience testing applications developed using Open Source Technologies in a large scale transactional environment (Linux, Apache, Perl, MySQL – LAMP)
Experience with Version Control (Git)
Experience with Release Management process/methodology

Senior Quality Engineer Resume Examples & Samples

Full-time architect and developer of scalable and maintainable test fixtures, tools and platforms
Scalable systems, virtual and physical
Mobile applications and supporting platforms (iOS, Android, Windows)
Any of the following programming languages: Java, C#, Python, Ruby, javascript
XML and/or JSON transport packages
Data-driven issue reporting
Bachelor's in CS or equivalent is required (Master's preferred)

Senior Quality Engineer Resume Examples & Samples

Monitors supplier performance and conducts supplier audits
Ensures timely resolution of supplier failure, corrective and preventive actions
Creates, updates and maintain quality system documentation
Represents the quality department in ECO meetings and serves as a member of the Material Review Board and/or Supplier Review Board
Conducts conformity inspections to support the ODA and customers
Makes substantial contributions toward determination of project goal/objective feasibility
Mentors and provides guidance to less experienced Quality Engineers (1 & 2)
Contributes to advanced technical research on new processes and technologies
Independently determines general approach and specific solutions to technical problems; works proactive and effectively with minimal supervision
Demonstrates good judgment in setting schedules/risk taking
Offers many suggestions to improves processes and authors new procedures as appropriate
Provides reliable solutions to a wide range of difficult problems using sound problem solving techniques
Exemplifies Garmin’s Mission Statement and Quality Policy and proactively works to improve Garmin’s image and culture
Excellent academics (cumulative GPA greater than or equal to 3.0 as a general rule)
Demonstrated strong and effective verbal, written and interpersonal communication skills
Demonstrates familiarity with detailed warehouse, manufacturing or service processes
Ability to prioritize and multi-task in a flexible, fast paced and challenging environment
Must be team-oriented, possess a positive attitude and work well with others

Senior Quality Engineer, Cast Iron Resume Examples & Samples

Either an Associates degree in an Engineering, Quality, Reliability or related field plus a minimum of 5 years of experience in a Quality Engineering related role OR a Bachelors degree in an Engineering, Quality, Reliability or related field plus a minimum of 3 years of experience in a Quality Engineering related role required
Work experience or training in Microsoft Office products with the emphasis in Excel, Word, and Power Point required
Ability to lead and train cross-functional teams required
Metallurgical, Foundry Operations, or Ceramic experience is preferred
Experience with Six Sigma (Green Belt or Black Belt) or Shainin is preferred
Knowledge of AutoCAD and Minitab is preferred

Senior Quality Engineer Resume Examples & Samples

Automate complex real-time customer scenarios and use cases and reduce test execution time and improve engineering efficiency
Work independently as well as in a team of engineers for testing VMware’s flagship products
Work with relevant parties such as PM, dev, support and ecosystem team to determine new features and enhancements, test requirements, test strategy, etc
Participate in review of feature and design specification
Develop test cases, using black, gray and white box testing techniques
Work with local and remote cross-functional teams
Extend test coverage/ Improve test methodologies and processes

Senior Quality Engineer Resume Examples & Samples

Prepare and update Quality system procedures/policies as required to meet applicable standards (TS16949, ISO, etc)
Responsible for the implementation and maintenance of the Statistical Process Control system
Responsible for product capability studies/analysis and other specialized statistical analysis as required
Analyze statistical data and initiate corrective actions or inspection frequency changes as needed
Customer and/or supplier liaison for quality systems to meet and exceed QS9000/TS16949 requirements through customer visits and building of customer relations
Responsible for preparation of Control Plans, and inspection instructions/check sheet as required
Promote and practice our “safety first” policy by addressing any hazards, defective equipment or unsafe situations immediately
Fill in for Quality Manager as necessary
Follows and supports Montezuma Manufacturing’s and Magna’s operating principles, including
Metal stamping and robotic experience required
Must have good organizational skills
Must be proficient in computer operations
Ability to read, write, analyze, and interpret internal procedures, documents and processes, internal and customer requirements, flow diagrams, and business correspondences
Must be able to work well individually or in a team environment, effectively interacting with all levels of the organization
Project management skills to work on several projects at once, driving each to completion
Ability to view all aspects of the system, seeing how each aspect interrelates within the organization

Senior Quality Engineer Resume Examples & Samples

Determine quality improvement parameters by identifying statistical methods relevant to manufacturing processes
Establish statistical confidence by identifying sample size and acceptable error; determining levels of confidence
Establish statistical reliability by using mean time before failure, weibull 3-parameter distribution, reliability modeling, and reliability demonstration tests
Develop experiments by applying full and fractional factorial techniques
Develop sampling plans by applying attribute, variable, and sequential sampling methods
Maintain statistical process controls by applying demerit/unit, zone charting, x2 charts for distributions and individual-medial/range for multistream processes
Analyze data by completing hypothesis, normal distribution, and process capability analysis tests
Prepare reports by collecting, analyzing, and summarizing data; making recommendations
Customer Service
General
Human Resources

Senior.quality Engineer Resume Examples & Samples

Learn new features and technologies enabled with VMware products and VSAN
Work with relevant parties such as PM, Dev, Support and Partner facing teams to determine new features and enhancements, test requirements, test strategy, etc
Review functional specifications and design documents
Define test strategy to ensure comprehensive test coverage
Develop test plans and test design specs for testing and delivering high quality VMware products
Setup test environments; help with reproduction of product issues, work with partners to drive resolution of automation/certification issues, verification of fixes
Work closely with development teams to resolve defects in a timely manner
Develop certification tests using Python
Maintain current hands-on knowledge of the VMware product line, specifically Cloud related solutions such as: vSphere, vCenter

Senior Quality Engineer Resume Examples & Samples

Test development for Networking and security products across VMware and Open Stack technologies
Test execution, automation, coverage improvement and providing debug support
Coordinate with development and deployment teams for VMware virtualization product testing
Analyze risks, create risk-based Test Plans and implement test initiatives
Review entire environment and execute initiatives to reduce failures, and improve overall performance
Document architectures, procedures, and processes for use by other cloud operators
Apply innovative testing to further improve quality of products
Communicate technical dependencies and concerns/issues of implementations
Cross functional engagement with various VMware’s engineering teams and program teams

Senior Quality Engineer Resume Examples & Samples

Help our client to achieve their real goals by understanding the requirements and coming up with best test coverage
Implement reusable automated test frameworks to drive test automation goals and to support continuous integration and regression testing. Utilize and extend existing test automation test harnesses
Execute testplan and manage all activities in the plan to ensure that objectives are met and that the solution works as expected
Test solutions in terms of functionality, performance, reliability, stability, security and compatibility with other legacy- and / or external systems
Understanding of Object Oriented Principles
Agile Experience
Common Purpose, Uncommon Opportunity. Everyone at Visa works with one goal in mind – making sure that Visa is the best way to pay and be paid, for everyone everywhere. This is our global vision and the common purpose that unites the entire Visa team. As a global payments technology company, tech is at the heart of what we do: Our VisaNet network processes over 13,000 transactions per second for people and businesses around the world, enabling them to use digital currency instead of cash and checks. We are also global advocates for financial inclusion, working with partners around the world to help those who lack access to financial services join the global economy. Visa’s sponsorships, including the Olympics and FIFA™ World Cup, celebrate teamwork, diversity, and excellence throughout the world. If you have a passion to make a difference in the lives of people around the world, Visa offers an uncommon opportunity to build a strong, thriving career. Visa is fueled by our team of talented employees who continuously raise the bar on delivering the convenience and security of digital currency to people all over the world. Join our team and find out how Visa is everywhere you want to be

Senior Quality Engineer / Software Engineer Resume Examples & Samples

Enable engineers to ship features with efficiency and confidence through gray-box testing, tooling, and robust automation frameworks, while providing the best end-to-end user experience across all platforms
Demonstrate exceptional judgement on projects about testing priorities, edge cases, incorporation of automation, and test plan execution
Keep your team and management informed of project progress and escalate issues when needed to the correct teams
Be an expert and source of knowledge on all aspects of the Yammer product
Support release management daily
Detect bug patterns and drive solutions to fix them
Participate in Yammer’s general QE/Product/Customer Support and Engineering initiatives
Respond to users in Yammer's bug-reporting groups, triage reported issues, and create tickets for legitimate bugs

Senior Quality Engineer Resume Examples & Samples

Curiosity: A desire to seek clarity of requirements and why tasks are done a certain way
Creativity: The ability to take a list of needs and insights and come up with other innovative ideas
Strategic focus: Skill to understand big picture and stay focused on task to achieve goals
Communication: Excellent interpersonal skills and be a team player
Excellence: Passion for high quality and efficiency
Evangelism: Be Comfortable leading meetings and discussions with non-technical teams
Leadership: Proven track record of responsibilities as a technical lead
Mentorship: A guide who can coach and mentor team members
Java and/or Objective Knowledge
Mobile test automation on iOS and Android

Senior Quality Engineer Resume Examples & Samples

Lead manufacturing and manufacturing partners in quality improvement activities
Track and report quality metrics to management and customers
Provide feedback and suggestions on corrective and preventive actions
Interface with engineering design teams to drive changes for quality improvement
Establish customer metrics and contacts for new products
Meet with customer periodically to review quality performance
Perform first article inspections
Complete warrants
Document and implement process changes
Issue corrective actions to suppliers and work with suppliers for closure
Travel to customer sites and work on any issues related to assigned business space
Work in a professional manner without direct guidance or direction from others
Support assigned commodities and act as the Supplier Quality Lead for these commodities

Senior Quality Engineer Resume Examples & Samples

Work closely with engineers to understand product changes and prioritize testing accordingly
Write and execute API-level automated feature and regression tests for current releases
Strong contributions to significant open source projects

Senior Quality Engineer Resume Examples & Samples

Design, implement and execute test plan against the core components of vRACK/EVO RACK
Automate functional and end to end test cases using Java and python and integrate into Continuous Integration Framework
Understand and integrate third party products and components to work seamlessly with the software
Ensure that proposed and existing architectures are aligned with organizational goals and objectives
Find product defects and follow up to closure
Develop innovate solutions in testing Converged and Hyper Converged Infrastructure domain

Senior Quality Engineer Resume Examples & Samples

Maintain Manufacturer’s Requirements Document for currency and accuracy
Oversee use, maintenance and designation of amusment attraction safety related parts and components
Approve and qualify Ride Law-related maintenance procedures
Ensure compliance of registered attractions with Florida State law
Partner with multiple WDW groups including Operations, WDI and Design & Engineering to improve safety and reliability
Perform audits on WDW attractions, transportation and entertainment venues
At least five years of mechanical engineering filed experience
Proven experience in application assurance of regulatory, international and industry standards and practices
Demonstrated experience in root cause analysis and hazard analysis techniques
Proven partnering and cross functional team leadership
Theme park experience
Comprehensive knowledge of ASTM F24
Two years auditing experience
ASQ
CSP

Senior Quality Engineer Resume Examples & Samples

Selects appropriate techniques for problem solving and makes solid and consistent Engineering and Quality Assurance recommendations
Has significant expertise in validation engineering and is thoroughly familiar with all regulatory requirements
Reviews and approves operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes
Champions continuous improvement and innovation from a quality perspective within the department right from vendor selection/approval through to customer awareness/satisfaction
Is an effective team member, fully motivated to achieve and demonstrate best practices in line with the department and LRP objectives
Works with EHS to identify significant environmental impacts of operations and to establish goals and targets around significant environmental impacts
Deals with suppliers, other engineering disciplines within and outside of Site and customers should the need arise
HETAC Level 8 in a relevant discipline
Minimum of 6-8 years' experience in a similar industry
Good technical capabilities, communication skills, teamwork abilities and initiative

Senior Quality Engineer Resume Examples & Samples

Work collaboratively with others as part of an agile team
Quickly pick up new technologies and learn new ways of solving difficult problems
Develop new automation against new features and new functionality in existing systems
Write clean, readable, and maintainable test code that can be easily explained and followed
Write clean, concise and effective test cases against features
Create automated functional and integration tests whenever possible to ensure the codebase has a high level of code coverage
Typically has 5+ years (or equivalent) developing test automation in a fast-paced environment
Proficient in at least one modern high-level programming language (Python, Ruby, JavaScript, Java, C#, etc…)
Ability to work with various test automation framework such as Selenium, Cucumber and Capybara
Ability to work collaboratively with development, product and UX in determining initial functional test coverage
Ability to troubleshoot issues within the overall system to pinpoint defects
Ability to work with relational databases (MySQL/Oracle/PostgreSQL) as well as NoSQL databases (Redis/MongoDB/Memcached) and design queries used for automation and troubleshooting
Must communicate effectively with team members, managers, and people in other areas of the organization

Senior Quality Engineer Resume Examples & Samples

Work collaboratively with design engineers providing guidance and participation in design inputs, design and development planning, design reviews, design verification and validation, and design transfer efforts. Review and approve design control and product documentation
Facilitate risk management activities including risk management plans, system hazard analyses, dFMEAs, and pFMEAs
Lead supplier management efforts, including supplier approval, supplier audits and developing quality agreements
Provide guidance on the selection of statistical analyses and sample size for design verification and validation and other testing
Support successful transfer of products to manufacturing by ensuring the adequacy of process validation, design transfer plans, quality plans and supplier documentation
Document, implement and manage quality system processes
Plan and execute internal audits at the site against applicable quality system standards, regulations and internal requirements
Education: BS or higher degree in engineering, or similar
Experience: 5 years minimum quality engineering experience in Medical Devices, including experience in leading design control and risk management activities. Experience in supplier management is a plus
In-depth understanding of design control and risk management
Working knowledge of the requirements of FDA QSRs, ISO 13485 and ISO 14971
Certification as an internal lead auditor for QSRs and/or ISO 13485 is a plus
Skills: Proficient in Microsoft Office. Experience in Minitab, JMP or similar statistical package
Must be a team player and possess strong oral and written communication skills
Applicants are encouraged to provide writing samples that demonstrate their capabilities in creating design control documentation and writing quality management procedures

Senior Quality Engineer Resume Examples & Samples

Responsible for quality of TripCase Connect product
Working in Scrum team with developers and product owner
Create and automate functional tests for new User Stories
Performs release regression testing
Support load/performance testing to assure scalability with rapidly growing user base
Analyze and document test results to ensure desired functionality and quality
Troubleshoot and isolate issues, file bugs and work with developers on resolving them
Daily builds results verification
Maintaining automated tests
Work closely with Product Owner on requirements for new projects in order to define quality needs
Propose improvements to software verification and release processes

Senior Quality Engineer Resume Examples & Samples

Bachelor's degree in Computer Science or Engineering discipline with 5+ years of relevant experience
Experience in development environment with a focus on Quality Management Systems with any of the following: CMMI, Automotive SPICE, ISO 9001, Six Sigma
Working experience of one or more Programming language (i.e. Java, C++, Python, Ruby, Perl, .NET, Objective C)
Innovative problem solving skills, analytical thinking in a team environment
Experience in Lean and Agile development and deployment methodology
Adept at learning new tools/new technology
Excellent communication skills: presentation, conflict resolution, customer focused, can communicate with all levels
Knowledge and application of Quality processes such as FMEA, 8D, Kaizen are a plus
Working experience with relational databases
Knowledge of Maven, Sonar, JIRA, GIT/Gerrit, Puppet, Docker, Jenkins, Electric Commander
Experience with Amazon Web Services a plus

Senior Quality Engineer Resume Examples & Samples

Facilitate the implementation of Quality Standards
Ensuring the necessary training and support is made available to the department and other functional areas. Empower and build self sufficiency within the area. Train and provide tools to the operational teams
Quality in Plant, Processes & Projects
Validates equipment/process/product changes from a quality standpoint. Ensures that quality is part of all working instructions. Support factory trials and review/approve new products and processes
Quality Skills and Attitudes in all Plant Teams
Layered Confirmation
Check that standards set within the area are adhered to through layered confirmation. Participate in daily performance review meeting (SIM), solves daily non conformity
Analyse & report on Quality Performance Metrics
Ensure that factory based Quality audits are carried out to verify compliance against defined standards and codes of practice. Audits will include, but not confined to
Hygiene Audits
Proven track record of progressively responsible experience in a QA/Quality Engineering Role
Degree or higher in a Food Science or science related subject
Proficient written, numerical and verbal skills
Proficiency and fluency of English language
Numerical ability to record, interpret and analyse key process data
Experience in validation or process and process equipment

Senior Quality Engineer Resume Examples & Samples

Drive process improvements in various functions in the business
Lead projects to ensure right first time tooling is produced
Develop lean systems and processes to ensure we respond to our customers' requirements in a timely manner
Ensure on time delivery of key projects
Support program to ensure a significant improvement in right first time metrics to customers both externally and internally
Develop and improve the QMS, ISO 9001, and identify any additional systems that would be of benefit to the company
Develop and implement effective auditing strategy to identify any weaknesses in the current system, and corrective actions to address these
Define and delivery on Continuous improvement projects
Supporting any projects related to process improvements
Support reviewing any non-conformances or customer complaints as required
Key Performance Indicators for the Quality Manager
Process improvement to increase right first time measures to both internal and external customers
Delivery of process improvement projects through setting SMART objectives
Coach and mentor staff in right first time methodology
Experience in manufacturing, and or engineering related industry
Experience in lean processes
Proven results in a similar role
Six Sigma Ideal
3 years' experience in quality
Proven results in Continuous improvement
Be a self-starter, and quick learner
Be proactive and energetic in the work situation seeking to get things done and at the same time deal with a variety of tasks
Adopt a serious and questioning manner in order to assess situations and come to conclusions, thus basing the process on facts and information gleaned from others

Senior Quality Engineer Resume Examples & Samples

Responsible for monitoring Nascote performance to customer assembly plants, including implementing corrective/preventive action, and liaison relationships
Responsible for Nascote QA Dimensional Lab, including Technician hiring, training, and supervision
Responsible for Nascote QA APQP and PPAP processes, including supervision and hiring of Quality Engineers and Engineering Technicians
Assist Quality Manager as necessary including coverage when absent and monitoring plant performance to customer quality requirements
Maintain positive customer relations and responsible reaction to customer concerns
Assign corrective actions (Quality Bulletins, 8D's, DMN's) as appropriate and approve responses as required
Review and approve deviations, correlations, control plans, FMEAs and Process Flow diagrams as required
Monitor and review APQP and PPAP development for Quality Assurance, including all dimensional and testing requirements, launch support and customer specific documentation (Schedule A, CARs, etc)
Fulfill Quality Engineer role for any specific programs assigned
Maintains positive employee relations within department, including: follows up on employee concerns / suggestions; resolves conflict situations; interprets and administers employee related policies
Motivates direct reports to perform their work with a high degree of quality and productivity
Ensures direct reports’ compliance with all safety, quality, environmental and BOS policies and procedures. Performs audits as required
Ensures employees receive the necessary training to perform their jobs, keeping them informed of any changes or new requirements
Assists direct reports by coaching and counseling employees as necessary per company policies
Conducts performance appraisals on direct reports in a timely manner
Applies disciplinary actions as necessary. Ensures fair and consistent treatment of employees
Maintains attendance records and approves time sheets. Approves vacation schedules
Provides support to employees in all technical functions of area of responsibility
Contributes to a healthy, positive and safe work environment
Maintains an acceptable attendance record
Promotes the maintenance of a clean and safe work area
Conducts work area meetings and ensures documentation is recorded and maintained
Leads and / or assists Task Forces, Launch Teams and Safety and Quality 8D Teams
Implements lateral moves, postings, layoffs and recalls in department as needed
Submits and implements cost reduction ideas and innovations and encourages direct reports to participate as well
Completes maintenance work orders and purchase orders
Writes department procedures

Senior Quality Engineer Resume Examples & Samples

Analyze requirements, develop automated tests and test strategies, and track defects for the deploying VMware/AirWatch applications across all devices (mobile/desktop) with a single identity and unified management
Perform both manual and automated tests on mobile and web based applications
Prior Behavioral Driven Development (BDD) or Test Driven Development (TDD) background that is competent in test script/framework automation using open source tools such as Cucumber, Watir, Selenium and Appium
Proficient particularly with Active Directory (AD)

Senior Quality Engineer Developer Resume Examples & Samples

Demonstrating Strong EQ (Be Aware) – Having a keen sense of self-awareness is the foundation of leadership at Adobe. Whether you’re an individual contributor or a people manager, you’re someone who’s empathetic and mindful of your impact on others
Role Modeling Check-In (Be a Coach) – We don’t believe in annual reviews and rankings. That’s why, feedback flows constantly at Adobe. To succeed, you’ll meet frequently with your manager to receive ongoing feedback, set challenging performance expectations, and pursue continuous development opportunities
Leading change (Be an Agent of Change) – You readily adapt to business changes. Ambiguity or uncertainty never seems to stop you from working productively. You’re maniacally focused on execution and you’re always looking at new approaches to resolving issues
Scaling the Business (Be an Owner) – You approach your role as if you own the business. The buck stops with you. Your goal is to always deliver an exceptional customer experience by listening to feedback and continuously looking to improve efficiencies

Senior Quality Engineer Resume Examples & Samples

Provides quality standards and guidelines for test driven development, continuous integration, deployment, operations and maintenance of service solutions
Designs and builds a scalable test framework for functional, integration, regression and performance testing
Participates in product roadmap discussions and identify key areas for improvement in the product and incorporates these goals into ongoing & future development initiatives
Track record implementing with build automation and continuous integration tools (Jenkins, Maven, Chef or Puppet)

Contract Senior Quality Engineer Resume Examples & Samples

Candidate is expected to work with globally distributed teams to engage early and provide continuous delivery of high quality software products that delight Sony customers. Must be results oriented individual with a passion to deliver quality next generation global media and collection of entertainment services to our growing customer base
Participates in product road-map discussions and identify key areas for improvement in the product and incorporates these goals into ongoing & future development initiatives
BS Degree in Engineering, Computer Science or equivalent experience
5+ years experience in software development, expert level of programming, design, and analysis
Recognized by your peers as having passion for quality and being customer focused
Hands on experience with building test automation frameworks (TestNG, JUnit), code coverage tools (Clover, Karma)

Senior Quality Engineer Resume Examples & Samples

Execution of both manual and automated testing based on test plans/test cases
Create and analyze product issues, document appropriately using online bug tracking application
Act as a conduit or liaison for information flow on product issues
Maintain expert level proficiency in the use of products
5 years of product quality assurance and testing experience to include but not limited to: testing on a variety of operating systems, including: Microsoft based products (NT, 2000, XP), Red Hat Linux distributions 7.x and above; design, testing and maintaining scalable, high availability solutions through design, implementation, and load testing phases, with experience recognizing potential scalability bottlenecks and recommending solutions; design and maintaining and testing a service oriented architecture with multiple internal and external customers
Advance knowledge in QA process and testing methodologies
Self-motivated, willing to learn new concepts and products quickly
Excellent Written/Verbal communication skills
Interpersonal skills to work with all levels of customers
Able to present difficult concepts clearly and concisely to both a technical and non-technical audience
Advanced technical skills and experience testing on a variety of platforms including web-based products, MS SQL Server, MySQL, .NET 4.0 WCF windows services, IIS 7.5, Silverlight, Adobe Flash, iOS and Droid

Senior Quality Engineer Developer Resume Examples & Samples

Test design, implementation, execution, debugging and automation in a large-scale test framework using Java along with basic Windows and Linux system administration
8+ years of Enterprise software development and testing experience
Broad technical knowledge including

Senior Quality Engineer Resume Examples & Samples

Certification solution architecture and design for partner Networking and security products for NSX
Test development, execution, automation and providing debug support
Coordinate with VMware and partner development and testing teams for solution certification
Analyze test results and debug issues with the partner products
Participate in programs to deploy pre-GA products, and provide direct feedback to product management and engineering
Review entire environment and execute initiatives to streamline certification process for multiple releases
Apply innovative testing to further improve quality of partner products
Cross functional engagement with various VMware’s and partner’s engineering teams and program teams

Senior Quality Engineer Resume Examples & Samples

2+ years of Quality Engineering experience
Bachelor's Degree in an Engineering discipline (Mechanical, Biomedics, Materials, Industrial, etc.) or related Technical field (Microbiology, Chemistry, etc.)
Exceptional analytical skills
Solid time management and problem solving skills
ASQ certification (such as CQA, CQE,CMQ/QE)

Senior Quality Engineer Resume Examples & Samples

Ability to lead, build and improve QA processes for Agile and waterfall projects, Test Design Optimization, Performance Testing, and Metrics & Business KPIs
Work with the development team to understand the technologies and develop / implement automated testing tools for quality assurance, data comparison and transformation (on Hadoop, Spark, Datameer, etc.)
Design, develop and deploy a test infrastructure that will support end-to-end verification of business flows
A deep, practical understanding of Quality Assurance processes
Technical knowledge and hands on experience in implementing a Continuous Integration (CI) solution on wide array of projects and technologies using enterprise tools such as Jenkins, Maven, Nexus and UrbanCode Deploy

Senior Quality Engineer Evening Shift Resume Examples & Samples

Provide quality engineering support to operations, including leading and support root cause driven approaches to problem solving efforts for quality issues
Recommend and advise on quality aspects of systems, tools, equipment, suppliers and procedures to ensure an effective, efficient and reliable QMS
Collaborate and partner with engineering and manufacturing operations functions to ensure quality standards are in place
Actively participate in the deployment of Operating System within the Plant 2 Operation and across the broader quality function
Work within project teams to establish process controls that ensure the safety and efficacy of the product, while minimizing destructive sampling
Partner with other manufacturing sites to ensure the requirements of the intra company quality agreements are agreed and achieved
Create, and approve Change Orders for the area in scope of responsibility
Lead QPI reporting activities, identifying abnormalities and generating and implementing cross functional response plans as required
Min level 8 Degree in Quality, Engineering or Technical/Science discipline
Min of 5 years experience working in Medical Device industry in a Quality / Engineering or equivalent role
Knowledge of IT systems (SAP/ QM) preferred
Demonstrates strong oral and written communication skills as well as demonstrating good organizational, presentation and project management skills. The ability to communicate effectively at all levels and with all functions in the organisation
Project and people leadership skills and experience desirable

Senior Quality Engineer Resume Examples & Samples

Leads a program for continuous improvement within defined area of responsibility that delivers process improvements for waste elimination and added value for the customer
Facilitates Level Two project management methodology for business to deliver said continuous improvement agenda
Communicates and creates awareness and competence for quality management in teams within defined area of responsibility to drive a highly focused 'Right First Time' quality culture
Designs, develops and delivers industry leading quality systems, processes and standards for monitoring, testing and inspection for fit and function for products
Designs, develops and delivers a set of specific measures and controls of the performance of the Quality System
Audits and reports on quality system effectiveness and maintains efficient process control documentation
Interrogates, analyses and evaluates data, systems and processes for trends and performance issues, draws inferences and creates useful insight for business process improvement
Conducts root cause investigation on Customer Complaints and internal Non Conformity Reports and ensures that corrective actions are implemented on time, accurate and complete
Manages and develops a competent and capable team of Quality Technicians in the execution of Quality Management System
Key Deliverables of SQE
Optimised lean and efficient processes within defined area of responsibility
Delivery of Level Two Projects on time, accurate and complete
Increase Right First Time
Decrease Customer Complaints and Operational Non Conformances
Reduce scrap and rework
Shape a quality driven way of working
Experience in Manufacturing, and or Engineering related industry
Experience in application of Lean methodology
Proven and demonstrable experience (+3 years) from a similar role in Quality
Ideally has experience in Six Sigma

Senior Quality Engineer Resume Examples & Samples

Bachelor's degree in computer science and engineering or equivalent work experience
Minimum 6-8 years of Software QA experience on Mobile apps and web applications
Excellent knowledge of QA methodologies, testing procedures, techniques and tools
Ability to create test plans and test cases by analyzing complex requirement, experience in setting up test environments, understand and execute test scripts with little supervision
Strong analytical and troubleshooting/debugging skills to resolve technical and business issues
Good verbal and written communication skill for collaborative team environment and technical documentation
Highly self-motivated, goal oriented and self-directed
Able to prioritize and execute tasks in a dynamic environment
Basic scripting/programming knowledge with fast learning ability
At least 5 years of experience various test tools such as MTM, Quality Center, ALM, Test rail, JIRA is required
Ability to test various API’s and have working knowledge of tools such as Jmeter, SOAPUI would be helpful to have
The candidate should have 6-8 years of experience in Automation/Manual Testing

Senior Quality Engineer Resume Examples & Samples

10-15 years of experience in a technology company
At least five, preferably 10 years of experience with complex systems that includes electronics, software, fluid and mechanical components
Must have a minimum of five years total experience in manufacturing and quality with at least two years working as a quality or test engineer in a PLM environment

Senior Quality Engineer Resume Examples & Samples

Monitoring performance by gathering data and producing reports
Supervising the program of internal auditing
Providing support to Regulatory and Customer audits
Provide validation expertise to maintain validated status for the facility
Minimum 2:1 honours degree in engineering, science or equivalent field
Minimum 7 - 10 years work experience ideally
Preferably experience in Quality Assurance, Validation & Process Improvement
Methodical and Committed to Quality
Be highly motivated, able to act on own initiative

Senior Quality Engineer Resume Examples & Samples

Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs
Conduct benchmarking to develop more effective methods for improving quality
Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges
Supports new product introduction as part of design transfer
Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate
Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process
Generate, review and approve IQ, OQ, PQ, TMV or Software Validation
Partners with Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed
Conduct stakeholder analysis to ensure that customer CTQs are known and adequately addressed in control plan
Develop measurement systems/capabilities, destructive tests, non-destructive tests for manufacturing processes
Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk
Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support

Senior Quality Engineer Resume Examples & Samples

Good understanding and ability to work with Microsoft Office
Basic understanding of manufacturing processes
Fluent in written & oral English
Basic understanding of project management
Demonstrated interpersonal skills
Ownership for supplier quality performance and measurement including KPI's and participate in supplier performance reviews. Enable reporting of metrics for monthly reviews
Lead quality issues with suppliers & partner with Internal Customers; Lead effective supplier containment and corrections/corrective actions
Act as point of contact for Internal/ External Customer groups on key compliance issues related to assigned suppliers
Responsible for accuracy and integrity of supplier data that ensures compliance with documented procedures & processes
Ownership and reporting on all quality issues associated with the assigned suppliers. Ensure all assigned supplier related material quality issues are effectively communicated to key stakeholders
Participate in the supplier material related processes which include: Material Review Board to ensure Coordination of MRB activities with the business unit to ensure the timely assessment of potential non-conforming products
Participate as required in SCRB in conjunction with key stakeholders
Support assessment of supplier changes
Participate in cross functional projects both locally & globally as required
Bachelor's Degree in Engineering or Science fields
Minimum of 2 years experience in manufacturing environment or equivelant
Good knowledge with GMP, ISO 13485, 21 CFR Part 820 standards
Good knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment
Demonstrated working knowledge to positively influence supplier quality performance
Analytical and problem solving capabilities with the ability to draw insights from data quickly and to define executable actions
Ability to plan, organize and implement multiple concurrent tasks
Strong communication/ influencing skills. Must demonstrate the ability to effectively communicate up/down and across different levels of the organization
Demonstrated ability to work in cross-functional team environments

Senior Quality Engineer Resume Examples & Samples

Manage, mentor and coach a high performing team of Quality Engineers & Technicians working on project based activities
Provide effective and responsive Quality support to project teams to meet their objectives of safety, quality & compliance, timeliness & cost
Communication and escalation of key Quality concerns/issues
Work cross functionally to ensure all process variables and their interactions are adequately defined, failure modes in process have been identified and appropriately addressed
Drive and implement process improvements to ensure predictable processes across all product lines (e.g. Risk Identification & Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities)
Ensure Regulatory compliance in area of responsibility to all medical device regulatory agencies (e.g. FDA , DEKRA, BSI)
Provide functional expertise to other support functions on quality related issues (e.g. Quality System requirements, regulatory requirements, statistical techniques, sampling principles)
Identification and implementation of appropriate statistical techniques to monitor process performance (e.g. In Process monitoring, SPC, CpK analysis, sampling techniques)
Approval of change requests for product, process and quality system changes
Customer complaints: Partner with Design Assurance to ensure appropriate focus on customer complaint analysis and trending through product commercialisation - taking action where required
Problem Solving: Lead a diverse scope and complexity of problem solving activity where analysis of data requires evaluation of identifiable factors. Exercise authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Demonstrate a broad knowledge of a variety of alternatives and their impact on the business unit
Validation: Align with Process Development and Manufacturing Engineering to identify and define appropriate process and product validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval
Support compilation of required Regulatory documentation (e.g.Technical files, Design Dossiers, Product transfer files, Essential requirements)
Champion key Quality Metrics for the Quality project team CAPA, Quality Incidents, manufacturing complaints, RFT, Audit results etc. Identify and drive improvement opportunities
Support the implementation of Lean Manufacturing across the site, in particular in new process development areas
Resource Management: work with Quality management to ensure appropriate project Quality resources are in place to support the project activity. Plans and organizes project assignments and maintains project schedules
Minimum of 4+ years experience within the medical device or pharmaceutical manufacturing industry - people management experience an advantage

Senior Quality Engineer Resume Examples & Samples

Assists internal and external contacts to resolve product and process problems. Investigates and solves manufacturing-related problems in assigned area using formal problem-solving tools
Analyzes and develops suppliers products to obtain maximum productivity and reviews performance in operation and provides suggestions for improvement
Champions continuous improvement efforts. Researches, recommends, implements and administers new and/or existing quality assurance processes. Engages in comparative and competitive analysis to ensure utilization of most appropriate and beneficial techniques in each situation respectively
Performs other duties as necessary. May supervise and provide work direction to other staff

Senior Quality Engineer Resume Examples & Samples

Bachelor's and/or Master's Degree in an Engineering discipline (Mechanical, Biomedics, Materials, Industrial, etc) or related technical field (microbiology, chemistry, etc.)
Experience in electronic quality system modules, such as ComplianceWire, CATSWeb, Documentum, QlickView etc
Working experience and expertise in CAPA and non-conformance systems
Exceptional problem solving and root cause analysis skills

Quality Engineer / Senior Quality Engineer Resume Examples & Samples

Game bench-marking for various game engines like, Frostbite, CryEngine, Unity, UE4, Ego Race Engine etc
Hands on & technical understanding XBOX One & Sony PS4 Console Gaming
Virtual reality, motion sensing for gaming & entertainment industry
Good knowledge of x86 PC Hardware & architecture, CPU, GPU, Chipset, Memory, Displays, Audio

Senior Quality Engineer Resume Examples & Samples

Responsible for planning and designing consumer-grade user experiences to the enterprise software market
Work with global engineering teams, including Business Development, Product Management, Quality Engineering and remote team to drive high levels of customer satisfaction and a high quality end user experience
Apply creative engineering solutions to solve challenging problems

Senior Quality Engineer Resume Examples & Samples

Work with engineers, managers, Product Management, QA, Load & Performance, and Operations teams to develop innovative testing solutions that meet market needs with respect to functionality, performance, scalability, reliability, realistic implementation schedules, and adherence to testing goals and principles
Design, develop and lead eBay''''s next generation QE initiative. As part of QE team, this individual will be responsible for the oversight and development of broad testing framework / unit, functional and integration testing
Estimate testing effort, prioritize projects, plan implementations, and help rollout system changes. Help define, and supervise the testing of complex, multi-tier distributed software systems and impacted domains that provide value-add from site quality perspective
Develop test plans test cases & test tools, and work with the development and other QA teams to ensure standard QA processes are followed including usage of Test Case management systems
Implement low level test strategies targeted at :Application and Component Frameworks, Presentation Infrastructure, Database Access Layer, Services Infrastructure including SOAP, Caching Systems, Common Rules Engine Services, Logging, Static and Dynamic Configuration Services and various Deployment Models
Identify process, technology challenges and deficiencies that need to be addressed and drive those changes to successful adoption
Influence development managers and architects to insure that appropriate levels of quality and testability is built-in to the design and code

Senior Quality Engineer Resume Examples & Samples

Quality leader and core team member on New Product Introduction (NPI) projects
Responsible for Quality Assurance (QA) support of marketed products. Support activities include change management, customer complaints, risk management, quality improvement and cost reduction projects, and compliance activities
Leader or team member of quality improvement projects to reduce costs and reduce customer complaints
Assessing and validating test methods and performing cross-over studies
Developing and analyzing shelf life and stability studies to set and validate our product claims
Assuring compliance to internal Standard Operating Procedures (SOP's) and external regulations. Leading Corrective and Preventive Action (CAPA), Risk Management, Risk Reviews, Material Review Boards, and change control
Interacting with and supporting our plant manufacturing locations (traveling to plant sites as necessary)
Helping to drive and foster a quality environment and mindset throughout the business
Minimum of two (2) years of combined experience working in a product, quality, engineering, microbiology and/or laboratory/technical function
Bachelor’s degree or higher in Mechanical Engineering, Chemical Engineering, Statistics, Chemistry, Microbiology or related discipline from an accredited institution
Minimum of four (4) years of combined experience working in a Product, Quality, Engineering, Microbiology and/or Laboratory/Technical function
Previous experience working in an FDA regulated device, combination, or drug environment
Strong demonstrated leadership ability and the ability to lead teams, drive change, and get things done
Previous experience leading QA efforts for marketed products and new product introduction teams
Previous manufacturing plant experience
Test method development and validation experience
Minitab and Microsoft Office proficient

Senior Quality Engineer Resume Examples & Samples

Lead the development and maintenance of the Consumer Business Quality Management System
Develop strong rapport and relationships with the CBG Divisional and Plant Quality Managers and Corporate Quality personnel
Consult and assist in document and process modifications for the transition from International Organization for Standardization (ISO) 9001 and 14001:2008 to the ISO 9001 and 14001:2015 versions (for CBG Plants only)
Configure and implement Corporate Enterprise Resource Planning (ERP) Quality Procedures for CBG requirements
Work in ENOVIA (eMatrix) system
Serve as a backup for the CBG Quality Analyst/Super User
Develop and implement training modules for quality systems in SAP Learning Solutions (LSO)
Minimum of three (3) years of experience working in a Quality, Laboratory and/or Manufacturing environment
Bachelor’s degree or higher in Engineering, Statistics/Mathematics, Science or related discipline from an accredited institution
Minimum of five (5) years of quality system experience
Working knowledge of ENOVIA (eMatrix) system
Working knowledge of 3M CFR and MDI systems (applies to internal applicants only)
ISO quality management implementation experience
Knowledge and experience with ISO 13485 (Medical), AS9100 (Aerospace) and Technical Standard (TS) 16949 (Automotive)
Experience in coaching and training of quality processes
Results oriented, self-motivated individual with proven ability to manage and complete multiple projects in a pragmatic manner and approach
Excellent interpersonal, verbal communication, technical writing and cross-functional teamwork skills
Experience in leading Greenbelt projects and/or participating in Lean Six Sigma projects

Senior Quality Engineer Resume Examples & Samples

Has working knowledge and understanding of global regulatory requirements and expectations for product registration and International Conference on Harmonization (ICH) Stability Guidelines
Support and/or lead efforts on stability process improvements
Designs, directs and conducts stability studies for drug substance, drug product, and medical devices to satisfy global regulatory requirements
Able to critically assess and statistically evaluate stability data to support establishment of specifications, drug substance/product expiration dating and label storage and shelf life claims
Independently authors well-written critical technical documentation in the form of technical memos, protocols and reports for use in submissions to world-wide government agencies for final market approval
Supports assigned projects as stability lead and works with team members to coordinate stability related project activities to ensure agreed upon timelines for deliverables are met
Identify and investigate any stability excursions and/or trend
Stay current with global regulations and ensure compliance for IPD products
Provide guidance to Product Assurance Engineers regarding the impact of product/process changes on stability studies
Mentor and coach the organization on applied statistical methods in quality engineering [Gage Reproducibility and Repeatability (R&R), inferential statistics, process control and capability]
Bachelor's degree or higher in a Science, Technology, Engineering or Mathematics discipline from an accredited institution
Minimum of three (3) years of experience working in a quality position focused on applied statistics
Bachelor’s degree or higher in Statistics, Mathematics, Engineering or related discipline from an accredited institution
Medical Device International Organization for Standardization (ISO) 13485 and Food and Drug Administration (FDA) Quality System Regulations (QSR) experience
Current Good Manufacturing Processes (cGMP) Drug experience
A working knowledge of ICH and international stability requirements is desired
Experience with oversight of drug substance and drug product stability studies to support drug development and product registrations is desired
Strong knowledge and use of statistics is required including ability to use Minitab
Ability to critically review and evaluate analytical data and make conclusions/recommendations based on data is required
Excellent communication skills (verbal, written and presentation) with significant amount of technical writing experience

Senior Quality Engineer Resume Examples & Samples

Act as Quality Assurance Manager for the site and Management Representative in relation to ISO
Directly supervises Quality Assurance Lead, Quality, Quality Technicians, plant experts and engineers including the preparation and delivery of staff performance evaluations and career development activities
Leads collaboration and coordination with site organization for factory, product service and process improvement initiatives
Acts as the customer advocate focal point for all items that are shipped to our customers
Representing the company externally for relevant quality issues
Responsible for the development, collection, processing/analysis, and interpretation of quality information including metrics, corrective and preventive actions
Reviewing, continuously improving, and authorizing all local procedures, manuals, instructions etc. as part of the quality management system
Assure compliance with global UOP QMS requirements for the functional areas on site
Performs quality audits at supplier’s site if required
Coordination of internal and external audits for all functional areas part of the site QMS.Support, train, mentor and coach plant leadership - Plant Manager and leaders, HOS Steering Team – and other functional leaders across UOP-Callidus
Utilize Lean tools and principles across all levels of the organization
Continually benchmark other Honeywell locations, gather best practices, and lead the appropriate incorporation into UOP-Callidus activities
Lead and or Participate on the Site HOS Steering Team
Drive breakthrough performance and expectations at the Beggs, OK site
Bachelor of Science degree or 6 years of experience in a Quality role in a manufacturing environment in lieu of a degree
Minimum of 3 years of Quality, Process or Manufacturing Engineering experience OR 3 years of technical experience in the Oil and Gas industry

Senior Quality Engineer Resume Examples & Samples

BE-Instrumentation/Electronics/Electrical
Certified Lead Auditor ( ISO 9001 ) / Internal Auditor
Exposure to Six Sigma / Lean ( preferably GB certified)
Should have flair for data analysis
Should have excellent knowledge in Excel & Power point presentation
Experience - 8+ years industrial experience with atleast 3-5 years in Quality Management system ( Non Manufacturing) . Experience to work as "Management Representative" is preferred
Candidate must have hand on experience of carrying out Internal audits in line with ISO 9001 requirement
Exposure to ISO 9001: 2015 will be an added advantage
Excellent written & verbal communication skill to work with leadership team

Senior Quality Engineer Resume Examples & Samples

A minimum of a Bachelors’ Degree in Engineering or related technical field is required
A minimum of 4 years of related experience is required
Technical training and/ or experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc
Understanding of the NPI process and Process Validation expertise is preferred
This position may require up to 10% travel and will be based Raynham, MA.Quality (Eng)

Senior Quality Engineer Resume Examples & Samples

Supports, consults, trains on, and leads quality improvement projects throughout the life cycle of Mentor products this includes product design and development, manufacturing, purchasing and improvements
Utilize statistical tools and techniques to establish sampling plans. Supports engineering activities in process and vendor specification development
Analyzes process-, product-, test- and Quality Management System data and investigates for improvement opportunities
Investigate instances of nonconforming material and facilitate the determination of cause, corrective action and recommendation of the disposition
Ensures that software validations are performed according to applicable FDA guidelines. Provides end user support by software validation throughout the Software Validation Life Cycle at The Netherlands Operations
Ensures risk documentation is up to date
HBO level in engineering or science
More than 3 years with Pharmaceutical/Medical Device companies
Knowledge of software and process validations
Extensive knowledge in Statistics

Senior Quality Engineer, Capa Resume Examples & Samples

Support the implementation of the standardized procedures, processes and systems for CAPA
Deliver education and interactive training for CAPA users to deliver consistent compliant CAPAs including Failure Investigation, CAPA Review Board and CAPA content
Assist CAPA users with development and documentation of problem statements, containment and correction, root cause, and action plan (including effectiveness monitoring) determination
Maintain overall management and effectiveness of the CAPA system including the process and application for applicable location
Roll-out and maintain site CAPA Review Boards including scheduling, execution and minutes
Ensure processes are in place to alert management of product quality & compliance issues for proper and timely escalation to CAPA
Provide CAPA compliance metrics and weekly management tracking reports
Implement measures to monitor the effectiveness of the CAPA system. Ensure results of verification and monitoring of the effectiveness of CAPA and its compliance to applicable regulations and standards of monitoring process are routinely communicated to management
Facilitate Change Management activities resulting from the standardization of the CAPA process and associated systems
Liaise with US CAPA Manager in establishing and implementing DePuy Synthes policies, procedures, and quality objectives
Liaise with the US CAPA Manager to align on system requirements to support the CAPA process
Identification and leadership of tactical continuous improvement opportunities
Identify opportunities for procedural harmonization and integration
Support audit readiness for CAPA
Partner on the formulation of responses to regulatory agencies in order to address CAPA related observations. Collaborate in the identification and implementation of corrective actions. Ensure effective and timely completion of all corrective actions

Senior Quality Engineer Resume Examples & Samples

Provide leadership in design & implementation of world-class quality engineering to support entire product life cycle with focus on quality engineering activities such as reliability, risk management, analytics/statistical techniques, requirements management, verification & validation, and design control across the lifecycle of the product. Activities would drive prevention, detection of defects at earliest phase of product design, continuous improvement & customer satisfaction
Provide leadership, technical expertise to ensure conformance to ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) based quality systems,
Provide review and approval for the release of new products ensuring quality requirements are met provide leadership & support to J&J process excellence initiatives including Six-sigma, design excellence & lean thinking
Direct development & consistent application of quality policies & procedures in product design & development, secondary development & transfer operations
Act as technical liaison, as needed, between product development, manufacturing, external manufacturers & suppliers
A minimum of 5 years of experience in medical device, pharma or another highly regulated industry is required
Six Sigma Green Belt, Black Belt, or Master Black Belt certification is an asset
Knowledge of Regulatory compliance: GMP, MDD (Medical Devices Directive), 510K (Pre-market Notification), PMA (Pre-market Approval), and Government, trade association, industry & medical publications is preferred

Senior Quality Engineer Resume Examples & Samples

A minimum of a Bachelor's Degree is required
A Bachelors Degree in an Engineering or Scientific discipline is required. An Advanced Degree in a related field is an asset
A minimum of 4 years experience in a highly regulated industry is required. Medical Device and/or Pharmaceutical industry is preferred
Quality engineering experience is preferred
Experience conducting Process/Design Failure Mode Effects and Analysis is an asset
Experience with Blueprint reading/literacy including GD&T is preferred. Familiarity with inspection methods and techniques is an asset
This position will be based in Raynham, MA and will require 10% travel.Quality (Eng)

Senior Quality Engineer Product Software Development Resume Examples & Samples

Participate and contribute to all phases of software as a medical device (SaMD) development lifecycle
Ensure products are developed and maintained in accordance with applicable industry standards and regulations including, but not limited to as IEC 62304, FDA guidance, FDA Part 11, ISO13485, ISO14971, IEC 62366-1
Provide technical support for audits of Software Suppliers and Software Consultants
Support regulatory filings and inspections
Review and approve software development plans, risk assessments, technical reports and deliverables associated the Software Design History File (SDHF)
University Degree in Computer Science, Engineering or equivalent studies
A minimum of 3-5 years experience in a regulated industry in quality assurance, new product development, or manufacturing engineering
Strong understanding of all regulations and normative requirements in regards to Medical Device Industry (ISO 13485, IEC 62304, ISO 14971 FDA QSR)
Experience with System Development Life Cycle for designing and developing of software and PEMS components to be intended as medical device or part of a medical device
Able to solve conflicts and work independently in a challenging fast changing international work environment
Well organized, self-motivated, creative and pragmatic
Solution-oriented, process-oriented and a team player

Senior Quality Engineer Resume Examples & Samples

A minimum of a Bachelor’s degree is required; concentration in Mechanical, Biomedical, Chemical Engineering or other similar scientific discipline is preferred. An advanced degree is a plus
A minimum of 4 years of related work experience in a highly regulated environment is required. A minimum of 2 years of experience in Medical Device, Biopharmaceutical and/or Pharmaceutical (BLA, PMA, 510K or equivalent) is required. Medical Device experience is strongly preferred
Some experience with New Product Development Processes is required. An ASQ Certification (CQE, CQA, CPGP, CMQ/OE) is a plus. Some experience collaborating with external suppliers is preferred. Working knowledge of Medical Device design controls and ISO 14971 is preferred
Intermediate knowledge in Statistics, Sampling Planning, Risk Assessment and Process Validation is required. A demonstrated working knowledge of 21 CFR 820, or similar industry regulations/guidelines such as: 21 CFR 210, 211, or 606, MDD, ICH Q8, Q10, or ISO 13485, is required
Knowledge and experience in aseptic processing, CIP/SIP systems, and environmental monitoring is a plus. Experience with Six Sigma training, tools and/or certification is a plus. Demonstrated ability to manage/lead Quality deliverables within projects is required
The position is located in Somerville, NJ, and will support the Ethicon Biosurgery group. The position may require 10% travel, based on business needs

Senior Quality Engineer Resume Examples & Samples

Minimum 5 years progressive experience in Quality Engineering/Quality Assurance role
Bachelor’s Degree Required. Master's Degree Preferred
Minimum 5 years experience facilitating or participating in root cause investigations using 5Y/8D or similar methods
Basic knowledge of Geometric Dimensioning & Tolerancing (GD&T)
Basic Knowledge of industry standard quality tools and processes
ASQ-CQE Designation not mandatory
Practical understanding of Management Systems
Demonstrates a good grasp of knowledge and principles of field of specialization and applies through successful completion of assignments. Successfully applies knowledge of fundamental concepts, practices, and procedures of particular area of specialization
Good interpersonal skills, ability to work well in teams, ability to make the right judgments and decisions; excellent critical thinking and problem-solving ability
Good analytical skills, time management skills, be self-motivated and self-directing and ability to proceed with minimal direction and information, good data mining skills and good computer skills, ability to self-learn, good networking skills
Excellent conflict resolution skills and demonstrated experience in working with multi-disciplinary and multi-level teams
Dedicated, flexible and highly motivated individual with exceptional communication and relationship building skills
Ability to travel domestic and internationally as needed – 10%
Basic knowledge of Medium Voltage Transformers and High Voltage Circuit Breaker products
Supplier quality or supplier development experience

Senior Quality Engineer Resume Examples & Samples

Responsible for Foundry Metallurgical support in Mapleton for number of part numbers
Responsible for Machine Shop Metallurgical support in Mapleton
Responsible for Seal Ring Metallurgical support in Mapleton
Works closely with the above departments with the main objective of providing advice and expertise for resolution of material failure problems
Responsible for failure and defect analysis of assigned castings and preparing and communication of reports
Maintains, calibrates and develops new set-ups and uses for test equipment in the laboratory
Responsible for analyzing test data and distributing metallurgical test reports
Coordinates service between the Metallurgical Laboratory and other departments with the purpose of providing advice and expertise on metallurgical testing problems and works with supplier quality, manufacturing and engineering departments in that capacity
Reviews and updates test procedures used in the Metallurgical Laboratory and develops new tests and writing procedures as required
Writes and provides input for Inspection Instruction Sheets that reflect Caterpillar requirements to suppliers
Writes purchase and work orders, provides support documentation to orders and handles routine metallurgical and personnel in absence of Metallurgical Engineering Supervisor
A 4 year degree in Metallurgical Engineering or Materials Science
5 years of experience in metallurgical engineering support and/or castings experience
Extensive background in engineering design, principles and mechanics and Foundry Technology
Good working knowledge of Quality Standards and manufacturing operations along with good communications skills are essential
Foundry/casting experience

Experienced / Senior Quality Engineer Resume Examples & Samples

Provide technical leadership to coordinate implementation of advanced quality processes including statistically based variation reduction, control planning, mistake proofing, and Manufacturing Process Control
Prepare progress reports, program reviews as needed, to assure the highest quality and cost effectiveness from the suppliers
You will be responsible for quality assurance processes including, but not limited to, First Article Inspection Requirements (FAIR), Self Release and product audits, as well as coordination of Quality System (AS 9100) compliance audits and special process oversight. In addition, you will be responsible for training and deployment of Manufacturing Process Control, variation reduction, quality requirement compliance, Six Sigma, and other Honeywell sponsored supplier initiatives
Demonstrated ability as a self-starting, self-directed individual
Demonstrated technical knowledge, strong leadership and interpersonal skills
Must have experience in manufacturing processes
Must have experience with Aerospace castings
Must be, at a minimum, trained in Six Sigma techniques
Must be proficient using common software (MS Word, Excel, Power Point, Project, etc.)
Experience using Honeywell specific software/management tools (ECATs, PDM, One Source, MACPAC, etc.) is a plus

Senior Quality Engineer Resume Examples & Samples

5+ years of Quality Engineering experience; leadership experience preferred
Manual manufacturing assembly experience
TS 16949 experience
Six Sigma experience preferred
Bachelor’s degree in Engineering or related discipline is required

Senior Quality Engineer Resume Examples & Samples

Work closely with key Sr. Operating personnel to ensure the QMS system is based upon their business needs and is aligned with the strategic plan
Conduct quality based risk assessments to determine the criticality of activities performed, and the competence of affected employees
Develop a comprehensive understanding of our Customer quality requirements
Provide support to the Planning, Proposal, and Development process. – (risk, RFQ review, exceptions etc.)
Review, approve and provide comment on specifications, drawings, plans and procedures
Provide QA/QC support to all client projects as assigned. Support entails but it is not limited to risk management, quality reporting, audit management and other project related activities
Compile and maintain detailed project Quality Assurance and Quality Control Plans
Compile and maintain detailed client specific Product Inspection & Test Plans
Responsible for the day to day management and development of program specific QMS internal audit program, NCR and CAR systems. Responsibilities include but not limited to planning, executing and reporting internal audits, processing of CARs, mentoring new auditors, maintaining system metrics and developing the QMS systems to meet the business challenges and goals
Prepare and troubleshoot corrective actions in relation to system related nonconforming events/near hits, adopting and promoting best practice use of robust root cause methodologies
Quantify, and analyze COPQ data and metrics reporting to local and global management
Support process monitoring and measurement processes through the development and implementation of statistical process control, where applicable
Work closely with Technical Assurance and Program Management to support the establishment of product and process control procedures, as well as quality triggers within the production and/or service process
Serve as Quality representative for client and 3rd party inspection site audits/meetings/visits
Ensure the independent asset, product, and component inspection function is in accordance with industry standards, regulatory statutes, and customer requirements
Provide support and leadership to the site, proactive quality programs including DFMEA, PFMEA, COPQ reduction projects, incident investigation and waste reduction projects
Ensure requirements that are critical to quality (CTQ’s) are defined, understood and aligned with current capabilities and are managed to ensure conformance
Develop processes that are based upon items deemed Critical to Quality (CTQ’s), and Critical to Process (CTP’s),
Actively participate in the development, execution and close out of program specific continuous improvement projects while working in a cross functional environment
Collaborate with business management and improvement teams to identify improvement opportunities and establish project goals, strategies, metrics and priorities
Support the organizations drive towards excellence in Health and Safety performance. Support includes but is not limited to conducting Stop observations, attending HSE related meetings, supporting HSE improvement projects and any other related task deemed appropriate by the Manager
Utilize the SmartSolve on line system to manage the fundamentals of quality assurance, provides meaningful data to the business leaders to drive improvement and align with the strategic direction
Support the customer satisfaction and loyalty processes
Bachelor degree in Engineering, preferably in Quality, Mechanical, Electrical and minimum eight (8)+ years of experience in Quality Engineering/Continuous Improvement role with demonstrable evidence of systems and process improvement
Must have extensive working knowledge of ISO 9001 QMS requirements
Experience of working in an environment such as oil & gas products, automotive, medical device is preferred

Senior Quality Engineer Resume Examples & Samples

Drive root cause identification on top issues and ensure short term/long term solutions and operating policies are instituted
Establish ‘Critical to Quality’ parameters for operations and be the gatekeeper to maintain these parameters within control so that PV modules meet proven quality/Reliability requirements
Identify, monitor, and improve quality issues incoming into cell manufacturing, as well as during & outgoing solar cell manufacturing
Responsible for conducting failure analysis of returned modules
Interface with cross-functional groups to drive and support Quality System improvement
Develop and implement various components of excellent quality system such as CAPA, RMA, Internal Audits, Problem Solving methodology across the company
MS Degree in engineering (electrical , chemical, material science, chemistry or equivalent)
5 – 10 years of experience in high volume manufacturing industry
Strong knowledge of Quality Systems (CAPA/RMA/ISO9001 Internal Audits etc.) is required
Experience/exposure working with lab level metrology/analytical tools (SEM/TEM/X-Ray Diffraction/EL/PL/IV Testers/Electrical Characterization of thin films) is desirable
Proficient in statistical data analysis, multivariate analysis, Design of Experiments (JMP preferred) and database queries (SQL)
Understanding of Continuous Improvement/Quality tools, SPC, 6 Sigma, and FMEA
ASQ Certifications for Quality Engineer or Six Sigma Certification would be an advantage
Excellent written and verbal communication skills required
Regular, reliable and predictable performance required

Senior Quality Engineer Resume Examples & Samples

Drive the continuous effort of high quality software delivery as part of an Agile Scrum team by way of planning, developing, debugging and executing test and test automation
The QE will understand the application under test, participate in all levels of testing activities, and work closely with all functions of the Scrum team as well as with surrounding teams DevOps, Test Engineering, Test Architecture and Environments
The QE will maintain and extend HMH’s custom UI and API Automation Framework (using Protractor, Selenium Webdriver, SOAP UI and other testing tools as required), which is a collection of commonly used automated testing tools, by adding features, implementing enhancements and fixing issues. The QE may also be involved with back end testing
The QE will automate the creation of test data to ensure a consistent test environment
The QE will build test harnesses to test software components at the most efficient level
The QE will influence and coach "design for testability" early in the development cycle by working as part of our product design team
The QE will work alongside developers in Agile sprints to develop test plans that form part of each story
The QE will define and execute a product quality strategy and actively participant in deployment with all levels of verification
QE will be involved in maintaining and executing UI and API test plans in Continuous Integration platform (like Jenkins or Bamboo), drive the effort of implementing efficient Continuous Integration / Continuous Delivery environment, and actively participate with setting and maintaining standards of good practices for functional and automated testing for frequent and effective execution. QE will adhere to automation ‘best-practices’ and standards to allow for easier collaboration among automation team members to increase the quality of the automation code
The QE will actively participate in the Scrum team Agile ceremonies like: sprint planning, daily stand-up, sprint retrospective, sprint review, backlog grooming, review delivery readiness, etc
The QE will participate in training and mentoring other team members to help develop better automation outcomes
Quality Engineers research and analyze new software test, test tools, and test automation techniques. Review processes and tools to avoid pitfalls that could happen in the future, thus reducing overall project risk
5 years of experience and a bachelor’s degree in computer science or related field
Experience working with Agile Scrum teams including participation in the following: sprint planning, daily stand-up, sprint retrospective, sprint review, backlog grooming, review delivery readiness, etc
Experience using automated testing tools like: Protractor, Selenium Web Driver, QTP/ALM, SoapUI, JMeter as well as backend testing
Good understanding of Object Oriented concepts
Experience in testing large scale distributed software platforms
Familiar with Testing Frameworks
Familiar with Test Design Patterns
Familiar with Release, Defects and Test Management tools
Experience with source control tools
Experience of working within a Continuous Integration environments
Familiar with Testing Frameworks like: JUnit, TestNG
Familiar with Test Design Patterns like: Page Object Model, Page Factory, Robot Framework
Familiar with Release, Defects and Test Management tools like: JIRA, QC/ALM, TestRail, QA Complete
Experience with source control tools like: Git, SVN, etc
Experience of working within a Continuous Integration environments using tools like: Jenkins, Bamboo, Teamcity etc
Working knowledge of testing web services
Detail orientated and ability to multi-task effectively
Quick learner and work efficiently and effectively independently and in a team environment
ISEB/ISTQB Certification

Senior Quality Engineer, Design Control Resume Examples & Samples

Site Quality Assurance project leader for new product introduction / design transfer process
Guides design transfer, design control, design verification, risk management and design review activities for the site
Identifies compliance issues and develops realistic solutions to meet & solve problems
Advises and evaluates product verification/validation activities
Collaborates with design team to help facilitate the successful development and transfer of new products
Performs process validation review for medical device components and/or assemblies processes for compliance to regulatory and statutory requirements in conjunction design and/or product specification
Facilitates risk management process in compliance to appropriate external standards and company policies
Provides technical support to design team in generating risk files for new products
Coordinates the documented quality planning activities supporting design control for the site
Applies quality concepts and tools including basic statistics to create and/or, interpret information and data as related to inspection, testing and validation
Develops and implement in-process tests and statistical sampling plans for commercial products from product validations
Assists in regulatory filings, updates and assessments
Ensure that all design control activities are performed in a manner that satisfies all necessary compliance requirements
Supports complex, cross-functional quality issues focused on the transfer of products to the site
Conducts advanced data analyses to determine quality problems and identify larger scale quality improvements
Provides quality specific training and guidance to the organization to correctly identify and define quality problems early
Works across functions with various internal and external customers to manage diverse quality issues
Leads cross-functional team projects
Determines clarifications and compliance to written standards providing additional information for the site to ensure consistent application of quality processes
Leads the establishment of compliant and efficient GMP processes related to the manufacture, packaging, testing and disposition of Class I, II and III medical devices and in-vitro diagnostics
Provides direction and support for the development and implementation of robust Quality Systems across regulated sites
Supports Global Design Compliance
Interacts both vertically and horizontally in a way that commands both personal respect and mission acceptance and possess the ability and interpersonal skills to influence all levels of the organization
Expert knowledge in design transfer, design control, design verification, risk management and design review
Expert knowledge of advanced quality tools, (e.g.: SPC, DOE GR&R, CPK Analysis, etc.)
Minimum of 7+ years related experience in Medical Device or Pharmaceutical Industry
Class II or III IVD experience is a must

Senior Quality Engineer Resume Examples & Samples

Development of project / process Validation strategy and Master Validation Plan
Review User Requirements, Functional/ Design Specfications and Design Qualification documents
Review and approve commissioning documents including FAT and SAT documents
Review and approve IQ, OQ, PQ, Test Method Validation or Software Validation documentation including deviation resolution

Senior Quality Engineer Resume Examples & Samples

B.S. with minimum 5-10+ years demonstrated success in Quality Assurance/Quality Systems or Technical Leadership role
5 + years in depth experience in either a Packaging Development, Process Engineering or Product Development technical role
Knowledge and experience in beverage processes including hot fill, high/low acid aseptic, dairy and retorting preferred
Proven ability to influence change management at all levels of the organization
Demonstrated skills and practice of Six Sigma/statistics and process capability/FMEA
Excellent leadership and influence management skills
Solid interpersonal skills in listening, coaching and communicating with integrity
Demonstrated skills in managing conflict and using data to drive decisions, even when unpopular
Fundamental understanding of food standards, safety and sanitary regulations and good manufacturing practices
Excellent organizational and interpersonal skills, knowledge of troubleshooting tools / techniques desired
Review assessments of company-owned, co-packer, warehouse and vendor facilities to ensure compliance to established procedures, requirements and specifications for new products prior to launch
Ability to communicate effectively across all levels of the organization
Fluent in English written and verbal (required)
30-50% travel required

Senior Quality Engineer Resume Examples & Samples

Providing Quality Engineering support for Repair & Overhaul Value Stream – supporting activities throughout the supply chain, understanding & developing processes use for manufacture of complex components
Interface with regulatory bodies / customers and stake holders such as project teams representing HAY Quality at all levels ensuring positive outcomes for the organization those customers / stake holders
Tactical operation and input into the Quality Management System to ensure it is developed, maintained, understood and executed by all associates, with special emphasis on product and processes in accordance with European Aviation Safety Agency, (EASA Part 145), Military Approval requirements and AS9100 including Customer or any other regulatory requirements as necessary
Tactical organization of Quality / Technical / Regulatory R&O training for all HAY associates in compliance with Honeywell, Customer and Regulatory requirements (e.g Human Factors/certifying staff Form 1’s, Part 145 Training as required)
Support and execute projects leading to AERO / HAY standardization, simplifying and improving existing Quality Assurance processes ensuring compliance with Honeywell AERO & Regulatory requirements
Drive built in quality (BIQ) and continuous improvement and Operating System (HOS from a Quality perspective within the Value Stream
Champion Problem Solving activities within the Value stream ensuring robust methodology used
Support the development and maintenance of technical documentation associated with manufacture and control of products and processes
Support and provide Quality expertise and direction within the Value Stream in association with Continuous Improvement activities
Management of Supplier caused issues within the Value Stream – liaison with Supplier Quality Team and management of the product / components within the manufacturing area
Excellent & demonstrable knowledge of CAA/ EASA Part 21/Part 145 / AS9100 Regulations with emphasis on repair organizations
Experience in Aerospace quality systems
Degree Qualified preferable
Proven problem solver and understanding of complex problem resolution having experience of tools used
Knowledge and experience of Core Quality Tools such as: Process Flow Charts, PFMEA, Control Plans, SPC and MSA would be an advantage
Experience / knowledge of APQP and PPAP requirements and expectations an advantage
Knowledge of SAP systems would be a distinct advantage but training in this aspect will be given
Good Sound knowledge of complex assembly, high precision machining, & associated manufacturing processes
Good knowledge and experience of reading and understanding complex engineering drawings and a good understanding of technical product and process knowledge

Senior Quality Engineer Resume Examples & Samples

3 years' technical experience on UPS
Good interpersonal and influencing skills
Strong track record of success
Fluent in English.Qualifications
Strong track record of success in

Senior Quality Engineer Resume Examples & Samples

Improve quality metrics, drive reductions in quality escapes through the development of systems and implementation of corrective actions. Improvement in First Pass Yield (FPY) of both pump ATP’s and paperwork deliverables (8130’s, analysis reports, etc.)
Develop and maintain repair station manuals compliant with FAA, EASA and CAAC regulatory requirements. Ensure that any regulatory changes are implemented within the allotted time frame
Host FAA/EASA/CAAC and customer representatives, and/or customer auditors (some of whom may be international with vastly different business cultures). This would also include being the MRO lead for AS9100 audits
Ensure timely completion of internal and external audits, ( technician, product, and system)
Manage the repair station Layered Process Audit (LPA) initiative, including the implementation of corrective actions associated with LPA non-compliances
Revise all support documentation as well as ensure compliance with our form control systems
Respond to corrective action requests from customers, regulatory or AS9100 system audits. Responses to including full root cause analysis, determination and implementation of permanent corrective actions
Collaborate with Technical Publications team, Engineering, and Customers, to improve CMM manuals. This position requires interaction with both internal and external personnel at all levels of the organization. Interaction is quite often providing the controlled interface between Eaton, the customer and regulatory bodies (FAA,EASA, CAAC)
Assist Product Reliability team in gathering data to resolve pump operating issues identified in the field. (i.e. leaks, excessive wear, in flight shut downs, etc.)
Utilize product audit process to suggest process and/or design changes to improve productivity and/or yield. Implement standard work; identify cost out opportunities, in order to drive continuous improvements in products and processes
Detailed knowledge of aerospace regulations, primarily FAR Part 145 and 43, EASA and CAAC. Experience with aerospace repair and overhaul practices, teardown and assembly processes and inspection techniques
Detailed knowledge of problem-solving techniques - Root Cause Analysis, 8D Corrective Action Process, and FMEA
Ability to manage multiple projects/activities/requests
Experienced in Microsoft computer applications: Excel (graphs, pivot tables), experience with large Word documents is critical, and Visio graphs, Outlook calendars, contacts, and tasks
Experience with government contracts, asset reporting/tracking, and contract required corrective actions
Trained in AS9100 quality system auditing
Working knowledge in aerospace quality processes specific to a repair station
Working Knowledge of drawings and specifications interpretation
Bachelor’s degree from an accredited institution required
Must reside within a 50 mile radius of the work location: no relocation provided

Senior Quality Engineer Resume Examples & Samples

Bachelor degree or above in mechanical engineering background
Have 5+ years experience in process quality control in mechanical industry, and supplier quality management skill; experience in electrical industry is a plus. If the background is very good and the candidate has high develop potential, 3 years working experience is also acceptable. Working experience in HMLV industries is preferred
Have experience with ISO 9001 and TS16949 quality system establishment and sustaining
Good communication skill, good command of English and Mandarin both in writing and speaking
Good at team building and strong team driver for process and system improvement
Good problem solving skill, identify problem root cause, completed prevent action
Good at quality tool application, such as 8D, APQP, PPAP, SPC, FMEA, MSA, etc

Senior Quality Engineer Resume Examples & Samples

Responsible for managing customer complaints related to the facility and for tracking, monitoring and initiating Customer Corrective Action
Lead cross functional teams in problem solving and issue analysis in an effort to address either customer or production related issues
Responsible for supporting production manufacturing with problem solving, process improvements and resolution to manufacturability issues. Directly supervises quality technicians and Inspectors
Directly supports ISO 9001 quality system and supports the implementation and management of the plants Quality System and procedures
Subject matter expert responsible for identify gaps at the Plant level and executing improvement activity. Execute or facilitate all aspects of APQP and Part Approval and sign-off for both suppliers and customers, manage revisions of process control documents such as PpFMEAs, Control Plans and other quality tools to ensure compliance
Works with suppliers to initiate and close Corrective Actions and to ensure that root causes have been properly identified and eliminated
Ability to lead and conduct Supplier Assessments to qualify potential new suppliers or evaluate existing suppliers. Works with the Supply Chain organization to develop new suppliers capable of meeting plant standards
Reviews supplier PPAP submissions including control plans and assists with control plan creation where necessary. Ensures all appropriate Significant Characteristics are included, that reaction plans are adequate and customer approval is obtained where necessary
Assists suppliers with statistical analysis and process capability (Cpk, Ppk) where necessary to improve performance or product quality
Works with Design Engineering and Supply Chain to ensure that quality criteria are clearly identified on all newly established parts and communicated to suppliers
Responsible for developing and leading routine risk assessment activity on all new products and with changes that affect existing product
Works in partnership with engineering to support all development projects and milestones related to Quality and improve the overall process to achieve zero defect quality and launch readiness
B.S. degree from an accredited institution
Minimum of 3 years of experience in manufacturing
Ability to work in the US without company sponsorship
Proven ability to solve problems utilizing common problem solving methodologies/tools such as PDCA, DMAIC, 8D, 5 Why, Fishbone diagrams, is/is not tables, pareto charts, control charts, etc
Proven ability to lead cross-functional projects
Proven ability to present facts and recommendations effectively in oral and written form
Proven ability to query and manipulate data using MS Excel, MS Access, Minitab, and/or other programs and transform the data into information
Proven ability to write technical documents such as procedures and specifications
ISO9001 or TS16949 Experience
Good understanding of lean concepts, principles & tools such as Value Stream Mapping, 5S, Continuous Flow Manufacturing, Set-up Reduction, Pull Systems and Standardized Work
Six Sigma Black/Green Belt certification
Certified Quality Engineer (CQE) or justifiable equivalent
Certified Quality Auditor (CQA) or justifiable equivalent

Senior Quality Engineer Resume Examples & Samples

Active participation in continuous improvement of the product
8D analysis related activities
Processes analysis and development of control plans
Research and investigation of data and evidence to develop quality alerts to help operators to focus on critical to quality characteristics
First article inspection reports development
Quality criteria interpretation according to internal workmanship and / or IPCA620A
Doubt clarifying and decision maker of process and product criteria
Development of PPAP of products
Review and analysis of nonconforming material detected during the different stages of the product, finish goods and returns from clients
Describe skills or specialized knowledge which this position requires (example: technical, scientific, administrative, managerial, etc.)
Quality control tools such as: Histograms, Paretos, etc
Software: MS Office, Minitab, etc
Problem resolution tools: 8D, 5 why, etc
Knowledge in AS9100 or ISO 9001 requirement
3 years’ experience in quality area minimum
PPAP and APQP knowledge
Experience developing control plans
Lean manufacturing and Six sigma
Bilingual English Spanish
Perform activities according to the Quality policies (EQS)
Complete annual revision of functional procedures
Active participation in Customer and Quality System Audits
CONTINUOS IMPROVEMENT RESPONSIBILITY
Leading Continuous Improvement activities in my area of responsibility through the deployment and utilization of Eaton Business System policies and processes, such as ELSS. CIF, PRO-Launch, EQS and others as applicable
Active participation in Ideas Program
Identifies cost out opportunities and work with Operational Excellence department to execute cost out projects
Attend training courses assigned
MESH RESPONSIBILITY
Perform activities according to the MESH elements, principles and methodologies to prevent accidents
Active participation on BBS
Report any activity that may put in risk my safety and environment or of my partners
Use of the proper EPP
Separate dangerous residues from the normal trash
Place the dangerous residues (Gloves, cloths, etc.) in the assigned containers
Maintain area clean and free of contaminants
Not waste of water or electricity
Identify and give adequate disposition to all chemical products, which can contaminate the environment
Acting immediately in chemists’ discharge case
Ensure the rights containers for disposition of dangerous residues (identifying containers and containers to prevent discharge)
Ensure the right storage of dangerous residues

Senior Quality Engineer, S Molton Resume Examples & Samples

Providing quality advice and expertise to our customers in respect of dealing with requirements, complaint resolution and taking corrective action
Supporting the quality team in collection and analysis of quality data, ensuring our policies and Quality Best Practice are adhered to
Executing the development, implementation and improvement of appropriate Quality Management Systems
Analysing organisational quality metrics and performing periodic reviews of products and processes and recommending improvements
Designing and conducting quality assurance training programmes
Participating in product development and developing and evaluating processes
Carrying out Potential Failure Mode and Effects Analyses as a preventative and corrective action strategy
Investigating and eliminating causes of quality problems and taking corrective action (8D Problem Solving)
Developing and implementing audit inspection and test plans; carrying out audits to the AS0100 standard
Ability to lead a small quality team
Thorough understanding of Lean and Six Sigma methodologies and problem solving methods as well as statistical tools
Knowledge of key phases and requirements of new product launching
Detailed knowledge of industry and customer specific quality certification (ISO9001, EASA Part 21)
AS9100 auditor qualification
Knowledge of gauging and product material properties
Understanding of engineering design
Ability to work with cross-functional teams within a matrix based organisation

Senior Quality Engineer Resume Examples & Samples

Act as the primary contact for customers regarding product quality issues including attending business review meetings and providing corrective actions as appropriate
Direct and lead the activities of warrant analysts in the failure analysis of returns
Participate on APQP and other cross-functional teams and provide input to the requirements for the review and approval of new or modified products, new or modified purchased components and new or modified processes. Review and approve completed PPAPs
Analyze internal and external quality loss data such as customer complaints, warranty, scrap, and first pass yield to ensure corrective actions are assigned as appropriate
Lead and participate in cross-functional problem solving teams
Obtain customer approvals as required by customer and internal requirements for modified products and processes
Act as a member of the Material Review Board (MRB) determining dispositions for nonconforming product
Provide oversight and guidance to suppliers on non-conformances. Review and approve supplier corrective actions
Provide statistical process control expertise and overall technical quality instruction and training to plant and division as needed
Assist with the creation, development, and implementation of company processes and procedures
Model the Eaton ethical conduct policy, the Eaton Values and Philosophy, and comply with all other corporate, plant, and regulatory policies and regulations as applicable
Experience in supervision for one year

Senior Quality Engineer Resume Examples & Samples

Utilize sound Quality engineering background to create, apply, and document quality control plans, process control forms whenever necessary
Support production engineering team for current production or new production introduction in terms of process control points, parameters, and related FMEA revisions
To initiate preventive, rather than corrective quality actions
Proficient application of core Quality Engineering tools/ principles, industry best practices and recognition for technical expertise (Ex.: 5Why, fishbone, PDCA, 6 sigma, Lean manufacturing, 5S)

Senior Quality Engineer Resume Examples & Samples

Provides Quality customer interface and expertise to proactively assure requirements are understood and satisfied
Executes the development, implementation, and improvement of the appropriate Quality Management Systems
Participates in the auditing of internal Quality Systems
Analyzes organizational quality metrics and performs periodic reviews to evaluate results and recommend action plans to close gaps at an operational level
Develops and analyzes statistical data and product/process performance
Participates in product development and launch activities
Develops, implements, and audits inspection and test plans, standards and acceptance criteria, and procedures/work instructions
Investigates and eliminates causes of quality problems and follows up on corrective actions
Educated ideally to degree or equivalent, in a quality or engineering related discipline. HNC or equivalent would be acceptable with appropriate engineering experience
Understanding of FAIR, LAIR
Knowledge of quality registration schemes ie ISO9001, AS9100,
Understanding of supply chain management
Knowledge of process auditing techniques
Knowledge of lean manufacturing, process variation reduction, six sigma
Knowledge of product application / specification requirements
Knowledge of gauging and control
Lead auditor would be an advantage
Good understanding of EASA part 21 and Part 145 regulatory approvals
Good understanding of quality tools (8D FMEA, FMECA, HEMEA)

Senior Quality Engineer Resume Examples & Samples

Coordinating the Supplier Partnership Program with Purchasing
Participating in supplier quality system audits and surveys
Reviewing and monitoring supplier interface from receipt of material through rejection notification and corrective action when necessary
Providing technical interface between suppliers and the plant on purchased products
Promoting quality consciousness, motivating personnel to perform and produce to the best of their ability with regard to quality and productivity
Helping to develop inspection procedures, plans, guidelines and records for all work areas to ensure the control of product quality is maintained
Assessing the need for new gages; arranging for their purchase or creation and assuring their accuracy by directing inspection, calibration and use
Keeping quality manager apprised of all issues in involving quality
Assist in analysis of material problems, investigate any issues and follow up, conduct any reliability testing necessary
A bachelor's degree from an accredited Institution
Four years of experience in engineering and/or quality in a manufacturing environment is required
The ability to work in the United States without sponsorship is required

Senior Quality Engineer Resume Examples & Samples

Provides Quality Assurance support to Suppliers, Customers and internal functions including Manufacturing, Assembly & Test cells and participates in continuous improvement activities in targeted areas
Executes the Quality Assurance strategy to ensure product flow consistent with established industry standards, government regulations and various customer requirements
Function as Lead Auditor to perform quality system audits at suppliers and internally to assess compliance to AS9100/ISO 9001 standards
Hosts & supports Internal, Customer, Supplier and Third Party Audits as required
Works collaboratively with applicable internal functional teams to improve key metrics including Supplier DPPM, RCCA responses and timely actions as issues are identified
Actively support Cost-Out, Scrap/Rework reduction & improved First Pass Yield site goals and objectives
Analyzes organizational quality metrics and performs periodic reviews to evaluate results and recommends action plans to Quality Manager to close gaps at an operational level
Contributes in using problem solving techniques & determining containment and Corrective Action solutions with applicable verification methods
May participate in product development gate review meetings with launch activities including identification of customer expectations ensuring compliance that Quality requirements are understood, flowed down and met
Apply engineering and manufacturing technical knowledge to help improve supplier activities that can help Eaton’s quality, delivery and cost performance objectives
Assumes lead Quality role in supporting Supplier Development and on-boarding activities
Responsible for all supplier key metric maintenance and reporting
Minimum of three (3) years of work experience within a Quality function
Legally authorized to work in the United States without company sponsorship now or in the future
Working knowledge of process auditing techniques to ensure compliance to defined quality requirements
Ability to learn product and end user application/specifications, including product testing requirements
Knowledge of product manufacturing, assembly, test and inspection processes
Willingness to ‘Think outside the box’ and can work well individually or in a Team environment
Work to resolve supplier technical issues in a timely manner to ensure a continuity of supply of compliant material
5 years of progressive experience in Aerospace industry
ASQ Certified Quality Engineer (CQE) and/or Certified Quality Auditor (CQA)
Customer-specific quality registration, certification processes experience (i.e. ISO9001, ISO/TS-16949, AS9100)
Previous work experience of problem solving methods such as: Six Sigma, 8D, root cause analysis, and the associated statistical tools used to analyze problems, evaluate and complete improvement projects
Working knowledge and experience in process auditing techniques to ensure compliance to defined quality requirements
Previous work experience in Lean Manufacturing and Process Variation Reduction concepts and tool sets as they relate to process/product variability, and root cause and corrective action determination
Familiar with and experience in product conformity requirements

Senior Quality Engineer Resume Examples & Samples

Establish and deploy audit schedule for internal and Fresh Eyes audits. Participate in Fresh Eyes audits at other Eaton facilities
Facility interface with third party certification body. Responsible to set audit schedule and agenda, and support third party audits
Responsible for a timely corrective action process that eliminates the root cause of Quality Management System non-conformances with the goal of no repeat issues
Responsible for Quality Systems support for Advanced Product Quality Planning. Have a solid working knowledge of APQP techniques as they pertain to Quality Management System and customer requirements. Participate on PRO Launch/APQP cross-functional teams and effectively utilize the tools, techniques and metrics in support of Eaton and Customer Quality System requirements
BS degree in Engineering or Quality related field
5 years experiences in development and deployment of Automotive quality systems including ISO/TS 16949, VDA 6.1, Industry, and customer specific requirements
Familiar with quality 5 tools : PPAP, APQP,MSA,CONTROL PLAN,SPC
Process audit and prod-audit ability
Documentation drafting(procedure, quality manual) ability
Knowledge of problem solving skills and ability to apply them
Effective communication skills. Fluent in written and spoken English
Certified Lead Auditor for ISO/TS 16949 Quality systems
MS office and Basic knowledge in computer operation

Senior Quality Engineer Resume Examples & Samples

Utilizes DMAIC tools to investigate non-conformances and participates in (CAPA)-related activities, including CAPA ownership
Utilizes engineering product development/process knowledge to solve straight forward problems (e.g., FMEA, Finite Element Analysis, Process Modeling, Design of Experiments, Molding, SPC)
Performs standard engineering assignments to support change controls and assists cross-functional teams in identification of risks
Supports product testing to ensure product conformance to specifications
Understands principles of complaint handling process and supports complaint investigations
Conducts complaint trend analysis and analyzes data from various sources (Non-Conformances, Field Corrective Actions, and Complaints) to drive decisions
Facilitates small project teams as needed to accomplish team objectives
Supports Quality internal and external audits as required
Display basic understanding of Quality Management System and GMP
Display a technical understanding of engineering and product development principles and procedures
Possess basic understanding of statistical process controls (SPC), measurement systems analysis (MSA), and DMAIC investigation tools
Familiarity with Minitab required
Display basic understanding of change controls and risk management principles
Experience in working with cross-functional teams, including technical and non-technical work
Ability to organize and present technical information with minimal assistance
Demonstrates solid organizational skills and ability to work independently
BS degree in Engineering. Master’s degree preferred
3-5 years related engineering/science/quality experience
Prior experience in product development, design and/or testing within medical device industry
Aptitude for mechanical design (i.e. tolerance stack-ups, material properties, solid mechanics, etc.)

Senior Quality Engineer Resume Examples & Samples

Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
5-8 years of experience with a Bachelor’s degree in Engineering or related technical discipline
3-6 years of experience with a Master’s degree in Engineering or related technical discipline
Previous medical device or regulated industry experience
Proficient with Microsoft Office tools including Word, Excel, PowerPoint and Outlook
Operations Quality Engineering background preferred
Must be able to work independently under limited supervision as well as in a team environment
Demonstrates good documentation practices and ability to maintain deadlines
Experience within Boston Scientific Quality System

Senior Quality Engineer Resume Examples & Samples

Leads the generation of risk management deliverables (risk analysis, risk evaluation, risk controls)
Proactively investigates, identifies, and implements best-in-class Quality Engineering practices
Identifies and implements effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
B.S. Degree in Engineering or Quality with 5-8 years of relevant experience OR Master’s Degree with 3-6 years of relevant experience
Experience facilitating risk management activities per ISO14971 is required
Medical device experience
Experience in supporting Quality related activities
Experience with facilitating CAPA related activities
Familiarity with Minitab and SPC Software
Experience with supporting Design Verification and Validation activities
Problem solver with the knowledge of problem solving tools, capable of facilitating problem solving process

Senior Quality Engineer Resume Examples & Samples

Evaluate business requirements and prepare the detailed functional and technical specifications that follow project guidelines
Work closely with Developers and Quality Assurance Analysts to ensure requirements and design are completely understood
Communicate design to all stakeholders and varying levels of the organization
Act as the liaison between Business and Systems Analysts, Developers and project management groups
Present and evaluate design solutions objectively and facilitate conflict resolution
Work closely with business teams to strategize solutions that support long term business objectives
Ensure IT deliverables align with business requirements with measurable results
Collaborate with QA team to ensure testing efforts align with system deliveries and business processes
Partner with Developers, System Analysts, Business Analysts, Technical Delivery Owners, Product Owners and Business SME’s to develop a robust Systems Integration test plan in an Scrum agile development environment
Responsible for developing integration test scenarios, QA project plan, coordinating test data setup, environment readiness, test execution and issue resolution
Lead/Guide Junior Quality Engineers to develop and implement Quality test strategy, test plan
Responsible to System/Integration test REST API’s, User interface, Database, reporting, ETL/Batch technology components
Responsible to work with various healthcare domain teams: Member, Provider, Network, Claims, Products, Benefits, Finance and Reporting teams so we have robust test plan and test outcomes
Perform complex testing with EDI X12 ((274, 278, 834, 837 etc) /JSON/XML API transactions
Explore new tools and capabilities to automate System integration testing so it supports continuous delivery/DevOps software development methodology
Participate and provide input in system analysis, design walkthroughs and Code reviews
Come up with innovative ideas/suggestions to resolve complex integration issues/defects
Present System-integration test results to the project teams and Business/IT leaders
Meet or exceed all defined target test goals and milestone dates for the project in order to ensure its overall success
4+ years of Quality Assurance testing experience in a web application environment testing User Interface, Database, Web services, API’s, Batch/ETL components
1+ years of hands-on testing experience working with complex XML/JSON, MQ interface, EDI X12, SQL transactions
3+ years of hands-on scripting/coding experience in any one of the below Java automation testing tools such as Spock, Groovy, Selenium, Gatling, JUnit, Geb, Cucumber, C++, .Net or other similar tools which uses object oriented programs
Exposure to incremental agile software development methodologies
Bachelor's degree in engineering or equivalent experience
Familiarity with Software Development Life Cycle (SDLC) / System Development Life Cycle
2+ years of Relational Database experience
Ability to anticipate problems proactively and take appropriate actions to mitigate negative impact
UnitedHealth Group work experience
Health care industry experience

Senior Quality Engineer Resume Examples & Samples

Drive reductions in Defective Parts per Million (DPPM) and improvement in First Pass Yield (FPY) of assembled products
Host customer representatives, source inspectors and/or customer Auditors as needed, and provide Eaton source inspection support
Collaborate with Design Engineering, Manufacturing Engineering, customers, and suppliers to improve manufacturing processes and develop methods to eliminate quality problems - Position requires interaction with external customers and internal personnel at all levels of the organization. Interaction is quite often providing the controlled interface between an Eaton manufacturing supplier (both internal and external) and the Eaton customer
Work with customer, government and other regulatory representatives to interpret or reach agreement on Quality procedures, and acceptability of products and assure compliance with the specified customer and government requirements
Investigate and resolve internal and external product quality problems utilizing Quality functional tools such as statistical and analytical tools, PFMEAs, and process capability studies
Utilize product audit process to suggest process and/or design changes to improve producibility and/or yield. Implement standard work, identify cost out opportunities, in order to drive continuous improvements in products and processes
Strong ethics, values and the ability to influence others’ decision making
Ability to manage multiple projects/activities; results driven
Knowledge of product and manufacturing process
Process oriented and ability contribute to continuous improvement
Knowledge of machining, assembly & test operations, gauging, SPC, and APQP
Detailed knowledge of AS9102 First Article and AS9103 Key Characteristic requirements
Bachelor's Degree from an accredited institution is required
Minimum of two (2) years’ experience in a quality role in a manufacturing environment
No relocation is being offered for this position. Only candidates who reside within a 50 mile radius of the Jackson, MS facility will be considered for this position
Experience working with Federal Aviation Regulations

Senior Quality Engineer Resume Examples & Samples

40% - Utilizes engineering background and expertise to communicate between team members and supplier counterparts to provide assurance that the hardware is compliant to specifications and drawings. Handles and communicates deviations/nonconformances at different levels within the organization, including disposition of nonconforming hardware and approval/validation of supplier corrective/preventive actions. Understands and communicates typical mechanical and electro-mechanical aerospace processes (machining, welding, NDT, etc.) and how they are applied to the hardware being manufactured. Acts as a team member with procurement and component engineering to engage critical suppliers to enable them to be successful
20% - Applies modern quality principles, concepts, and methods to aerospace and manufacturing operations, including Lean Manufacturing and Six Sigma tools
20% - Interprets engineering drawings and specifications, customer quality requirements, and company quality requirements to ensure compliance with the customer's expectations
20% - Prepares comprehensive analyses, procedures, reports and presentations for customer/supplier review throughout the evaluation process. Reviews all supplier data and ensures that it is complete and accurate

Senior Quality Engineer Resume Examples & Samples

Design and implement quality testing strategies for various HomeAway sites and services
Proactively drive quality through collaboration, process improvements, and tool creation
Take ownership of projects and provide quality leadership
Demonstrate advanced knowledge of automation techniques at each level of the code stack
Show successful hands-on experience testing on complex application suites
Use creative solutions to solve complex problems
Participate in design discussions, reviews and propose/implement quality test plans and strategies

Senior Quality Engineer Resume Examples & Samples

A minimum of a Bachelors Degree, preferably in Engineering or related technical field
A minimum of 4 years of related experience
This position may require up to 10% travel and will be based Raynham, MA

Senior Quality Engineer Resume Examples & Samples

Provide Quality Engineering representation on Product Development Teams
Initiate new or revised documentation
Lead cross-functional teams to develop risk assessment
Develop physical and functional test methods to ensure specifications are met
Write, review and approve design verification and validation protocols and reports
Develop processes validation requirements (IQ, OQ, PQ) and equipment qualifications
Conduct and /or coordinate testing outlined in protocols and test methods
Perform process improvement, control and monitoring on manufacturing processes
Provide technical direction during design transfer activities
Conduct complaint investigations
Participate and provides input to training on department/division procedures, and policies
Participate in project planning, budgeting, scheduling and tracking
Coordinate and lead internal and supplier audits
Develop and implement procedures to comply with corporate and industry standards
Understand and follow company procedures on regulatory requirements
Provide support to the regulatory department in writing technical submissions
Provide positive example and actively promotes compliance to all standards
Maintain a professional working relationship with internal and external customer and support staff
Demonstrated Project Management skills
Advanced statistics
Engineering cost analysis
Advanced product, design & prototyping skills
Ability to create and provide training
Advanced problem solving skills
Ability to create, review and coordinate test protocols and reports
In-depth knowledge of regulatory requirements
Ability to develop and control a budget
Ability to manage technical personnel
Ability to perform design review functions
Must read, write and understand English. Must be detailed in handling information/data

Senior Quality Engineer Resume Examples & Samples

Participate in cross-functional teams at various phases of the development cycle as the Quality Engineering and Quality Systems representative
Work independently and with project team members to develop design control deliverables including quality plans, manufacturing and inspection documentation, test methods, and Device History Records
Assist with the development of project verification and validation activities
Participate in the development and maintenance of product risk and hazard analysis and management for multiple projects in accordance with ISO 14971
Identify manufacturing and development constraints. Work with management and technical staff in performing root cause failure analysis and implementing corrective and preventive actions to preclude recurrence
Develop and Implement Test and Inspection processes for Incoming Materials, Work In-Process and Finished Devices, including all necessary validation and qualification activities
Work independently and with project team members to develop and improve product and processes to reduce variability and increase robustness throughout the development cycle for multiple projects
Prepare regular performance reports for Quality Management Systems, Operations, and project development. Maintain associated databases and design reports to reflect management input and changing organizational needs
Assist in the performance and documentation of internal and external audits in accordance with internal and supplier auditing schedules
Respond to audit findings by proposing and implementing necessary corrective actions
Responsible for reviewing and verifying non-conforming materials and initiating and following up on associated corrective actions as required
Meet company and departmental goals in the continuous improvement of all products, services and processes
Perform final product release activities, as needed, in accordance with established procedures and production schedules
Assist in troubleshooting/root cause identification for issues affecting manufacturing floor
Lead Nonconforming Material process (NCMR) including investigation, analysis and chair of the material review board. Report out on NCMR metrics
Identify manufacturing process improvements – generate process verification/validation protocols
Work with suppliers to address material/component issues, ensuring consistent input into manufacturing process
Develop and implement Incoming Inspection Plans for higher risk materials/components, ensuring only conforming materials/components enter product stream
Perform Final Release Inspections, as required, to support timely product delivery
BS/BA in Engineering or a technical field
5+ years experience in quality field in a medical device or similarly regulated industry
Experience with software and software/hardware development within a regulated industry

Senior Quality Engineer Resume Examples & Samples

Improves products through implementations of quality management policies, procedures, specifications, test methods and measurement systems
Develops new and/or improved processes and techniques for engineering tasks
Develops product reliability assessments and reliability test plans
Responsible for review and approval of drawings, calculations, specifications and other design inputs/outputs
Provides direction in developing inspection plans, First Article Inspection, In-Process and Final Product Inspection, Sampling Plans, inspection and acceptance criteria and Design Validation Testing
Monitors and/or performs quality activities to support First Article Inspection
Applies sound systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Coordinates and participates in elements of investigations regarding customer complaints
Minimizes customer complaints due to product quality through effective corrective actions and preventative actions
Ensures compliance of project activities to appropriate regulations and standards (FDA, ISO, EN)
Partners with Manufacturing, Marketing, Regulatory, and R&D functions to define requirements for new product development
Performs process capability studies or special studies necessary to increase control and lower total quality costs
Initiates and directs corrective actions to problems relating to product or process quality
Communicates essential Management Review data to senior leadership such as complaint trending and analysis
Global/Business Perspective
Motivating Others
Negotiation/Influence
Minimum of 7 years of experience with Quality Engineering in the food, drug, or device industry required
Medical device Quality Engineering experience strongly preferred, but not required
Supervisory experience strongly preferred, but not required

Senior Quality Engineer Resume Examples & Samples

Supervise personnel within an area of the Quality Department. Take the lead in this area
Develop and modify Procedures and other related procedures
Participate/support the Management Review Process
Participate in and lead cross-functional teams as directed by the Quality Manager
Participate in and lead internal/external audits as required
Strong communication, organizational and project planning skills
Ability to write engineering documents, test protocols, FMEAs
Able to analyze and chart data using MS Excel or Minitab

Senior Quality Engineer Resume Examples & Samples

4+ years of experience with a Bachelor’s Degree
2+ years of experience with a Master’s Degree
Experience in vascular devices, embolic coils, stents, catheters, balloons, aspiration devices, coatings and/or guide wires
Strong oral, presentation and technical writing skills
Demonstrated skills in decision making – preferably across a broad spectrum of Quality Engineering responsibilities
Risk analysis
Highly proficient in math and use of statistical techniques
Design of experiments
Lean principles
Reading and correcting drawings
Knowledge of sampling methods
Six Sigma background strongly desired
Certified Quality Engineer (CQE) / Certified Biomedical Auditor (CBA) preferred
Mastery of relevant software programs preferred – Microsoft Word, PowerPoint, Excel, and Project, and Minitab

Senior Quality Engineer Resume Examples & Samples

BS degree in Engineering or Science
5+ years experience in a highly regulated field
5+ years expertise in Class (II) or Class (III) Medical Device Industry
Certificate of Professional Engineer (PE) or MS Degree
Lean Sigma training or certification
Certified Quality Auditor (CQA)
Knowledge of GMP, ISO 13485, MDD, CMDR, CMDCAS
Training in Process Improvement
Good written and verbal communication skills
Quality Engineering Statistical Tools
Good people management skills
Supervisory skills
Effective project management skills

Senior Quality Engineer Resume Examples & Samples

4+ years of quality, reliability, or product support engineering experience
Bachelor's or Master's Degree in Engineering, Material Science or related field
Engineering tools utilization experience such as design of experiments, risk management, validation, methodical problem solving and statistical analysis to resolve quality issues in a manufacturing environment
ASQ Certified CQE, CQA or CRE
Experience working in a quality system in medical devices or other highly regulated industry
Knowledge of Geometric Dimensioning and Tolerancing (GD&T)
Experience developing, implementing, and maintaining software in a validated, GMP environment
Experience supporting manufacturing automation and IT systems
Knowledgeable in the current state of the art quality systems, gauging methods and equipment
Organized and able to attain results on several projects simultaneously
Ability to transfer technical expertise by teaching, developing and mentoring Medtronic employees and supplier personnel
Values others ideas and experienced working in a team environment
Ability to work well with a diverse group of people
Results-oriented
Computer experience is required; MAPICS or an equivalent production control computer system and computer database experience desired
Working knowledge of applicable regulations and standards (including, but not limited to: ISO13485:1996, ISO 13485:2003, AIMD, 21 CFR 820)

Senior Quality Engineer Resume Examples & Samples

B.S. degree in engineering, physics or science
4+ years related engineering experience
Demonstrated engineering field of expertise such as mechanical, electrical, biomaterials, etc
Demonstrated ability to effectively manage complex projects
Demonstrated ability to solve complex problems in creative and effective ways
Demonstrated advanced team leadership skills
Demonstrated excellent organizational skills
Demonstrated excellent verbal and written communication skills including ability to effectively develop and present complex technical information necessary for the company
Demonstrated excellent analytical skills
Medical device industry experience
Proficiency with personal computer software including word processing, spreadsheet, and statistical programs; computer aided drawing and project scheduling
Demonstrated advanced understanding and application of Quality System requirements, including FDA GMPs, ISO 13485 and ISO 9000 and documentation procedures
Ability to learn Medtronic systems quickly
Familiarity with biomaterials and their properties
The noise level in the work environment is usually quiet to moderate

Senior Quality Engineer Resume Examples & Samples

Experience in compliance with quality standards in a regulated environment
Experience conducting audits, CAPA investigations and Continuous Improvements (CI) projects
Proficient in use of SAP and TrackWise
Courage - Ability to identify, analyze and solve problems with minimal direction and make decisions with confidence
Accountability – Strong attention to detail and accuracy
Ability to successfully balance and prioritize multiple ongoing projects/tasks (Project Management skills)
Passion to Win - High degree of initiative and self-motivation

100

Senior Quality Engineer Resume Examples & Samples

B.S. in Engineering or associated scientific discipline
Minimum 4 years medical devices experience in Quality or R&D Engineering position
DFSS or DMAIC Black Belt Certified or Certified Quality Engineer (CQE) or Certified Reliability Engineer (CRE) preferred
Proficient with Minitab
Experience and success working with multi-disciplinary teams
Exposure to or experience working in or with Design, Quality, Development Engineering, Clinical Affairs, and Manufacturing
Knowledge of Design for Reliability (DfR), Design for Reliability and Manufacturability (DRM), and robust design practices
Working knowledge of product risk management standards and tools (ISO14971, IEC 60601, pFMEA, dFMEA, etc.)
Working knowledge of Quality Engineering and medical device regulations (FDA 21CFR80.820, ISO13485)
Working knowledge of electro-mechanical devices, software hazards analysis, and/or plastics related manufacturing processes (i.e. extrusion, injection molding, RF welding, etc.) is preferred
Reliability engineering experience, including product performance modeling and trending
Proven ability to operate in a matrix organization and navigate complex business systems, regulations, standards, and performance requirements
Excellent PROBLEM SOLVING skills, including demonstrated application of structured problem solving methods and tools
Demonstrated CRITICAL THINKING skills with focus on improved system performance outcomes and positive business impact
Strong written and oral COMMUNICATION skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience)
Strong COLLABORATION and INFLUENCE skills (build relationships, leverage others, align and work towards shared outcome-based goals, understand others’ needs, negotiate for win-win, own the whole)
Fluent in English (both oral and written)
Proficient in word processing, spreadsheets, and managing electronic data files

101

Senior Quality Engineer Resume Examples & Samples

Demonstrated understanding of Medical Device Quality Systems and Risk Management concepts
Demonstrated understanding of Six Sigma and Lean methodologies, specifically in the areas of root cause analysis and process improvement activities
Demonstrated understanding of electronics, electromechanical and software design and manufacturing processes, in order to support designing, troubleshooting, refining and qualifying the design to ensure the sustainable manufacturing of medical devices both internal and external
ASQ Certified Quality Engineering (CQE)
Experience with Geometric Dimensional and Tolerancing (GD&T) and the ability to read blueprints
Knowledge of and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO13485, ISO14971, IEC60601, IEC62304 and ISO62366 requirements
Experience in manufacturing in areas that support designing, troubleshooting, refining and qualifying the design and processes to ensure the sustainable manufacturing of medical devices both internally and externally
Excellent organizational and communication (oral and written) skills. Ability to work on teams as well as individually. Able to set and meet goals. Organized and detail oriented. Problem solving and analysis skills

102

Senior Quality Engineer Resume Examples & Samples

Bachelor’s Degree in Engineering, Engineering Management or Science / Lifescience
4+ years experience in the medical device, pharmaceutical or regulated industry
4+ years combined experience in Quality, Supplier Quality, Supplier Management,
Green Belt or higher certification
Experience with CVG Quality Management System
Medtronic certified lead auditor (ISO 13485)
Experience with manufacturing ERP/MRP systems such as JDE, FACTORYworks, SAP or Navision
Experience with LIMS systems such as MAQS
Master’s Degree in Engineering, Engineering Management or Science / Lifescience
Working knowledge of FDA QSR, ISO 13485, ISO 14971, IEC60601, UL2601-1, EMC Directive, and other appropriate industry standards
Well-developed interpersonal communication, decision-making, problem solving, influencing, and leadership skills
Ability to work with internal and external customers
Ability to work in a collaborative and cross-functional (matrixed) team environment
Regulatory compliance audit experience
Demonstrated ability to successfully lead and/or participate on project teams
Working knowledge of process improvement skills including Lean Six Sigma or DRM
Experience in application of statistical methods to assess conformance of products to requirements
Engineering tools utilization experience such as design of experiments (DOE), risk management, validation, methodical problem solving and statistical analysis

103

Senior Quality Engineer Resume Examples & Samples

Bachelor’s degree in engineering discipline
5+ years Quality Assurance experience in a GMP environment or highly regulated industry with a BS degree. 2+ years with a Master’s degree
ASQ certification
Must be able to effectively communicate at all levels and across company lines
Six-Sigma greenbelt or blackbelt certification
5+ years of Quality Assurance experience in a QSR (GMP), disposable medical device environment
Knowledge of Cell Operating System
Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), JPAL, and ISO 13485:2003n and JPAL
Demonstrated working knowledge of process validation, statistical methods, risk management
PC skills, word processing, spreadsheets, project management, etc

104

Senior Quality Engineer Product Development Resume Examples & Samples

Responsible for all Quality and Compliance related functions within the site
This includes direct oversight into the Quality review and lot release activity, Engineering Studies, Validation Protocols, Document Control and Change Process, Calibration and Instrumentation Program, Environmental Monitoring and Pest Management
Position is responsible for overseeing the overall effectiveness and acceptability of the Quality System and working with management to resolve opportunities
Performing training on cGMP and various Quality related items throughout the year will be expected
Tracking, trending and reporting of Quality issues on a monthly basis will be required. Writing of Exception Reports and CAPA plans as well as performing Compliance audits will also be expected
Proper execution of the requirements of this position assure the AN-Richmond site meet or exceed the Abbott and Regulatory requirements for Compliance

105

Senior Quality Engineer Resume Examples & Samples

JOB PURPOSE
Document quality systems and programs in the areas of management responsibility, auditing, quality trends, quality costs, training, validation, design controls, purchasing controls, corrective and preventive actions, process control, customer complaints, calibration, documentation control, etc. to ensure compliance with FDA, and regulatory requirements
Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality
Monitor manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained
Review the adequacy and correctness of changes to Bill of Materials (BOM’s), Assembly Procedures, Drawings, Component Specification, etc
Specify and develop special inspection equipment, fixtures, and procedures in conjunction with manufacturing
Ensure that the disposition non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent reoccurrence
Develop and establish statistical sampling plans for validation, incoming inspection, etc
Develop and execute training programs (e.g. change control, GMP, risk analysis, statistics, etc.)
A minimum of a Bachelors Degree with 5 - 7 years work experience or equivalent experience in related industry
Competence in the selection and use of Quality Engineering Tools and Techniques
Ability to effectively communicate written and verbally
Expert knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR etc.)
Certified Quality Engineering (CQE), Certified Software Quality Engineer (CSQE), Certified Reliability Engineer (CRE), Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA), or Six Sigma Green Belt desired

106

Senior Quality Engineer Resume Examples & Samples

Participate in requirements, design and review meetings
Develop test strategy, test plan, test design specification, test matrix and risk assessment leading to successful implementation and timely project completion
Create, maintain and execute test cases/test scripts (manual and automated) for all tiers/components of assigned systems (UI, web services, data warehouse etc.) in accordance with regulations, quality standards and design controls
Develop test scripts for validating web services using API
Deploy products to QA environments and maintain them to support testing efforts
Producing manifest of builds prior to release along with deployment instructions
Define and execute load and performance tests in conjunction with Developers and Product Owners
Collaborate with cross-functional teams to ensure timely and effective testing as part of a regular release schedule
Train, mentor and collaborate with other QE Engineers, both local and off-shore on assigned releases
Assist with defining and implementing quality improvement initiatives
8+ years of experience in Quality Assurance of Enterprise applications
4+ years of experience in web-based enterprise application testing and technical/domain expertise in ERP and CRM solutions (Salesforce experience is desired)
2+ years of hands on experience in developing and maintaining automated test frameworks
Demonstrated experience using tools like SOAPUI, JMeter, TestNG, Load Runner or any other equivalent test tool
Experience with one or more programming and scripting languages such as Ruby, Python, Perl, Groovy, Java or JavaScript is required
Experience testing web services and/or REST API validation using JSON/XML required
Solid knowledge of RDBMS, SQL, SOQL, SOSL
Excellent people skills with the ability to mentor team members and educate others on testing principles and methodologies
Ability to work proactively, independently or as part of a team on multiple tasks and projects, and quickly learn new technologies
Experience working in an Agile/Scrum-like environment required
Excellent written and verbal communication as well as technical documentation skills
Ability to prioritize and drive to results with a high emphasis on quality
Experience in cloud based technologies or COTS solutions is desired
Experience in SaaS or Cloud environments
Experience in working in a regulated environment (SOX, HIPAA, CLIA, GCP, and FDA)

107

Senior Quality Engineer, Data Analytics Resume Examples & Samples

Serves as the area technical resource for routine and ad-hoc complaint and complaint related analytical reporting
Identifies, develops, recommends, improves and reports out meaningful and actionable metrics and KPIs
Facilitates the evaluation of complaints, including investigation, containment, review, approval and determination of on-going needs
Identifies product and process improvements to reduce complaints and cost of poor quality
Provides support in the administration of the customer product communication process as needed
Represents and supports area as a subject matter expert in support of audits and inspections

108

Senior Quality Engineer, Complaints Resume Examples & Samples

Serves as the area technical resource from the chemistry aspect of complaints and complaint related items
Ensures adequacy of complaint records, investigations, and corrective actions
Promotes global awareness and adherence to policy and procedures
Coordinates the evaluation of complaints for potential adverse events and potential field actions and ensures issues are elevated as required
Provides support in the execution of field actions as needed
Provides support in the administration of the customer product communication process
Participates in improvement projects to advance processes and capabilities

109

Senior Quality Engineer Resume Examples & Samples

Provide quality leadership to new product development teams in the areas of design control, design verification and validation, design transfer, process validation, risk management, and specification development
Ensures adequacy of complaint, non-conformances and CAPA records, investigations, and corrective actions
Provide consultation to end users and process owners with regard to data collection, analysis and creation of validation reports
Other activities as assigned

110

Senior Quality Engineer Resume Examples & Samples

Ensures adequacy of non-conformances and CAPA system, practices as well as records, investigations, and corrective actions
Identifies product and process trends and drive improvements to reduce complaints, non-conformances and cost of poor quality
Collaborates deeply with other Illumina sites and partners to implement new processes and also promotes awareness and adherence to policy and procedures
Responsible for the enhancement of NC and CAPA data mining/ analysis for the purpose of identification, escalation and containment of internal and field product quality issues
Represents NC and CAPA areas as a subject matter expert in support of audits
Participates in enhancement of NC and CAPA track and trend, risk determination, failure investigation/ root cause analysis and other improvement projects to advance processes and their capabilities
Develop and monitors process metrics and action plans as needed
Provides recommendations for business process improvements as they are identified during the analysis, tracking, and trending of quality review inputs
Provides management with status updates on assigned responsibilities and goals and escalates issues with respect to these responsibilities and goals in a timely fashion

111

Senior Quality Engineer Resume Examples & Samples

Review Design and Development paperwork, records, etc for compliance to internal procedures and regulations
Ensure proper justification of statistical analysis and hypothesis testing
Review technical repmis as well as documents for Design History Files
Participate in device risk management activities including UFMEA, DFMEA, PFMEA
Aid in establishing proper statistical controls in development and transfer to manufacturing processes
Verity data integrity, electronic data storage and data sheet validations
Review and coordinate with QA Validation for all test method and design validations
Review activities related to Design Verification and Design Transfer of Medical Devices
Ensure work product meets regulations
Support scientific, complaint, and test failure investigations
Perform data trend analysis, where applicable
Participate in Phase Reviews
Write Quality Procedures, as applicable
Perform Data/Statistical analysis as needed
BS in Engineering and 6+ years or MS in Engineering and 4+ year experience in the combination device or medical device industry. CQE preferred. Six Sigma Black Belt preferred

112

Senior Quality Engineer Resume Examples & Samples

Responsible for CoE integrated quality system for development of Platform Primary Packaging components, covering both compliance aspects to GxP regulations and best development practices for drug delivery system components
Primary interface of CoE with Global and Local Sanofi quality organization
Ensures that test methods developed in Functional Testing, Material science and Chemistry lab are validated according to the appropriate standards, depending from the intended use
Ensures that Platform Component specification and AQL are based on appropriate analysis of user needs and user risks
Act as a Global SME (Technical) for quality aspects related to Primary Container, beyond compliance, including Risk Assessment, Requirement management, development Study design and statistical analysis of results
Support transfer of Platform component documentation to R&D DP Centers and IA manufacturing centers. Support integration of data in integrated drug delivery product DHF and filing dossiers, in liaison with other stakeholders (BioPharm and Pharm Dvpt Centers, IDLS-PSO, SFD, SFI, Global regulatory and Global quality)
Support key supplier and technology partners for all quality aspects related to PFS/PP Platform component development and supply
5+ years in the quality functions related to engineering or development of parenterals
Exposure to multiple functions across R&D and Industrial Operations
Demonstrated knowledge in quality and design development systems

113

Senior Quality Engineer Resume Examples & Samples

Expert in facilitating root cause analysis sessions utilizing quality tools and techniques like Ishikawa diagrams, 5 whys, pareto, P/D FMEA, & 8 discipline method with a focus on NPI's (New Product Introductions)
Collaborate with Quality Control (QC) Manager to establish, review and improve test methodology, criteria and testing plans for incoming and in-process inspection performed by quality control. Ensure plans are appropriate to confirm product quality and help to identify potential issues through product life cycle
Ability to facilitate meetings and interface with all departments, customers, suppliers and subcontractors to address quality related issues. Drive corrective actions and progress through our CPAR process
Strong statistical analysis knowledge and experience performing statistics and training others in tools like Graphs and bar charts, SPC, MSA, Gage R&R, Capability analysis, variation & distribution analysis, DOEs and experienced in using statistical software as a regular tool (i.e. Minitab)
Drive the appropriate development and use of Quality Dashboard & other metrics for ISO compliance and effectiveness to WMC. In partnership with Quality Analyst, perform analysis and provide appropriate reports on manufacturing quality levels and participates in nonconforming material disposition and corrective actions
Conduct audits on production employee’s skill set and certify they have the right understanding of the CTQ’s (critical to quality) to perform their jobs
Implement a robust Quality Near miss program to ensure countermeasures and controls are engineered solutions rather than administrative controls whenever possible (i.e automation, Poka-Yoke, SPC, LPA)
Develop and conduct training on Quality Concepts to key groups within quality and operations
Conduct improvement projects, perform data search, plan, propose and implement changes. Track results through metrics and graphs
Understand critical characteristics and develop/update control plans for each production area
Bachelor's degree in Quality or Industrial Engineering from four-year college or university. Minimum of 5 years of experience in Quality Engineering or related role. Experience working in manufacturing environment is preferred
Six Sigma, Kaizen, Lean, and/or ASQ Certifications is a plus
Strong organizational, presentation, priority setting and communication skills. Analytical thinking, initiative, integrity, and organizational awareness
Ability to use Microsoft Office programs proficiently. Strong Excel, Access, and Visual Basic
Excellent communication skills with the ability to interact with all levels within the organization
Strong ability to work in a team environment
Must be able to travel and work at our Mexico facilities (Tijuana area)
Bilingual (Spanish/English) skills are highly desired

114

Senior Quality Engineer Resume Examples & Samples

Provide technical input on quality and contractual issues to internal stakeholders and external customers
Serve on the following boards and teams: Quality Representative on Configuration Control Board, Chair Material Review Board , Inspection Review Team, Integrated Product Teams, Corrective action team
Review design concepts and technical documentation
Perform necessary tests with equipment and effectively document test results
Formulate or help formulate quality assurance policies and procedures
Compile and perform various reports and audits
Development and modification of procedural documents
Assist with the implementation of quality standards and regulatory requirements
Conduct training on quality assurance concepts and tools
Perform all operations according to prescribed safety and environmental principles
Interprets engineering drawings and specifications, customer quality requirements, and company quality requirements to ensure compliance with the customer's expectations
Experience with Quality assurance in a design and manufacturing environment
Defense Contract Management Agency (DCMA) experience
Experience with FAR Part 145 and 21
Experience with regulatory requirements, Government/Military contracts,
FAA experience
National Aerospace and Defense Contractors Accreditation Program (Nadcap) experience
Experience working in an Aerospace Industry

115

Senior Quality Engineer Resume Examples & Samples

Serve as the primary quality resource to department supervisor(s) for problem identification, resolution, loss reporting and continuous improvement
Prepare part approval documentation in accordance with company and customer procedures
Participate as team member for warranty teardowns and analysis
Review customer and quality non-conformances and coordinate corrective and preventive actions
Assess customer line returns at customer facilities on monthly basis
Train and supervise auditors for product and process auditing and the use of inspection and measuring equipment. Train and develop subordinates
Ensure that manufacturing adheres to required material and in-process specifications: Emerson, UL, CSA, and government
Perform internal audits
Follow-up on and close pending Preventive and Corrective Action Request
Oversee calibration and testing program
Insure quality systems and training are in place by developing and delivering training material on quality standards and activities
Participate in continuous improvement activities, as directed by Quality Manager

116

Senior Quality Engineer Resume Examples & Samples

Preferred B.S. Degree in Engineering with additional hands on experience in quality engineering or equilvance of 5-7 years of work experience in a quality engineering role
Hands on experience on 8D, 5Y, FMEA, MSA, SPC
Experienced in GD&T including being capable of transferring specifications and drawings into control plan/quality inspection plan and work instructions
ISO9001 or AS9100 or TS16948 experience is essential
Advanced Product Quality Planning (APQP) experience is preferred
Lean and Six Sigma knowledge is highly preferred
ASQ certification and/or a strong fabrication background is preferred but not essential, as is experience with SAP

117

Senior Quality Engineer Resume Examples & Samples

Able to lift 50 pounds occasionally
Use hand tools and devices requiring manual dexterity
B. S. in Mechanical/Electric/Electronics Engineering or related field
Solid problem solving/analytical capability
Knowledge of 8D’s, Ishikawa, 3X5W, etc
Familiar with Quality Systems/TS16949 knowledge preferred
A high level of self-initiative
Blueprints, tolerance, and measurement
Industrial Statistical Process Control
Electronic information / communication systems, networks, computer systems, etc
5 to 7 years manufacturing experience in the automotive industry required, (preferred)
2-3 years experience with electrical component manufacturing preferred (electric power assisted steering a plus)

118

Senior Quality Engineer Resume Examples & Samples

Ability to lead problem solving teams and processes
Good communication skills, both oral and written
Proficient in basic computer skills

119

Senior Quality Engineer Resume Examples & Samples

Support continuous integration process improvement and innovation
Write test plans and test cases (automated)
Troubleshoot critical defects in software coding
Work closely with the Developers and Engineers and product management in an Agile environment (two week sprints) to achieve a high level of code coverage

120

Senior Quality Engineer Resume Examples & Samples

Prioritizing and planning all assigned projects for the QA validation department
Creating master validation plans and schedules
Leading validation project planning
Facilitating risk analysis
Perform/review failure investigations
Documenting & executing qualification protocols and reports
Facilitating change validation
Supporting raw materials, formulations, and facilities qualifications
Supporting/executing DOEs and process characterization studies
Developing validation training modules
Implementing new or changed quality systems (programs/policies/procedures)
Conducting validation and statistics training for Operations, QA, IT, and MSE personnel
Develops, enhances, and implements validation programs/policies and procedures for manufacturing equipment/process and computerized (automated) systems, including training programs
Leads validation activities/projects. Creates reviews and/or approves software, equipment, facilities, formulations, and product/process validation documentation, including site validation master plan
Implements programs/policies/procedures with respect to Revalidation, Commissioning & Qualification, Sampling Plans, Process Capability, Root Cause Analysis/Failure Investigations, and Risk Management
Proactively examines systems, processes, and standards to identify areas for review, change, or elimination. Establishes linkages to other quality systems/programs like Technology Transfer, Change Management, Test Method Transfer, and CAPA
Provides consulting, training and guidance on validation principles, risk management, root cause analysis, statistics, and quality systems
A minimum of a Bachelor's degree is required; a degree in a technical field is preferred; an advanced degree is an asset
Minimum 4 years work experience in Validation/Statistics/Process Engineering/Test Method Development within the Medical Device and/or Pharmaceutical industries required
Certified Quality Engineer (CQE) certification is preferred
Excellent understanding and application of principles, concepts and practices of Risk Management, Statistical Methods, Validation, Commissioning & Qualification, Root Cause Analysis/Failure Investigation, and the QSR/ISO Regulation is required
Excellent communication, interpersonal, conflict management, and organization skills is required. Strong leadership and coaching skills is required
Proven ability to manage by influence, especially in leading change required
Ability to work in a cross functional environment is required
Excellent verbal and written communication skills as well as superior analysis and problem identification skills is required
This position may require up to 10% domestic and international travel and will be based in Jacksonville, Florida

121

Senior Quality Engineer Resume Examples & Samples

May execute the following resposibilities
Monitoring Systems by becoming familiar with systems applications and critical process steps; and through familiarization with methods used to reduce process variation
Becomes familiar with Product/Process improvement efforts by understanding current quality metric data and learning the various analysis methods used to enhance sustaining product design and new product development
Learns Quality Tools & Training Materials by gaining knowledge of prevalent tools used and by reviewing & utilizing available training materials
Evaluates new equipment and processes and participates in the transfer of new products

122

Senior Quality Engineer Resume Examples & Samples

Bring a quality mindset to our development of end-to-end systems that help people with disabilities. Such systems are composed of real-time robotic-like motion control systems, audio and video signal capture and processing, inference and decision making, speech and natural language processing, and new user interfaces, especially those driven by touch, depth sensing, haptics, etc
Put in place the systems to ensure we release software with low bug count
Work to meet regulatory requirements for quality systems
Interface with multiple teams within Microsoft Research, Microsoft Ability, and other groups
Experience creating a quality mindset in a team and leading the team in shipping quality
3+ years quality assurance experience
5+ years of professional experience in designing and developing software and hardware-software systems
Experience across multiple software languages such as C, C++, C#, Python, and Javascript
Experience working in a distributed software engineering team including code review, branching strategies, pull requests, and git
Experience collaborating with academic/research teams
Master’s degree or similar experience

123

Senior Quality Engineer AQE Plant Resume Examples & Samples

Implement World Class Quality Systems
Continue improvement MEQ Quality Deliverables for the assigned manufacturing plants (JIT, OHS, IP-DP, Seat Components)
Is responsible to ensure that continuous improvement is made in all Production MEQ Quality Deliverables (e.g.: RPPM, CPPM, IPPM, SPPM, Quality Costs, Customer Product Audits and Warranty / JD Power)
Prepare necessary corrective / preventive actions, follow up, verification and release of corrective actions
Assure that all Quality activities are performed according BOS-, TS 16 949-, ISO 9000 standards and specific customer requirements
Represent plant in Program SDT Team, assures execution of plant related PLUS tasks
Manage execution of Customer Part Submission, assures customer acceptation
Maintain and controls Customer Part Submission documentation
Maintain customer approved Customer Part Submission Samples
Give training and guidance and professional support to staff
A Bachelor´s degree is required (or equivalent experience)
Specific education and training in Quality disciplines including as a minimum QS9000, Continuous Improvement, Total Quality Management, PPAP, FMEA, Control plans, DOE and SPC are also required
Candidates may have these requirement waived only by the Advanced Quality Manager (or equivalent)
Minimum 7 years in the Automotive Industry
Minimum 5 years in Quality area
Knowledge of the AIAG Quality planning and Control Plan standard, FMEA´s, PPAP´s, Dimensional layouts, gage/fixture design and Performance/Material testing
Manufacturing Quality system experience and customer communication activities
Certification in Quality Engineering a plus. QS9000 certified auditor training desirable
Requirements may be waived based upon work experience

124

Senior Quality Engineer Resume Examples & Samples

Review functional specifications and test cases to understand the functional and technical requirements, then provide feedback to the Development and Quality Assurance teams
Design, develop, and maintain test automation scripts and automation tools
Participate in the continuous improvement and optimization of the test automation model
Review test case design, testing schedule, and control worksheets and provide feedback to the Quality Assurance team to ensure test automated script can be developed and maintained
Develop enterprise Java applications used for testing and developing automated tests and testing frameworks
Solve problems and perform deep root cause analysis
Knowledge of Java SE, Java EE (Servlet, JPA, JAX-RS)
Familiarity with web technologies like HTTP, REST, HTML, and JavaScript; experience with Angular is a plus
Understanding of relational databases, preferably Mongo
Working knowledge of UNIX-like operating systems and networking
Experience with Maven, Git
Security experience is a major plus
Experience with LDAP, Kerberos, or SSO servers is an advantage
Experience with OAuth, OpenID Connect, or SAML protocols are beneficial
English communication skills and the ability to read technical documentation

125

Senior Quality Engineer Resume Examples & Samples

Define automated test strategies, methodologies, processes, and procedures
Work directly with other storage automation team members and developers
Bachelor's degree in IT or computer science, with 5-7 years of related experience and training; equivalent combination of education and experience will also be considered
Experience with continuous integration and automation frameworks is highly desirable
Background in test-driven development or Agile methodologies is an advantage

126

Senior Quality Engineer Resume Examples & Samples

Work with a team of other engineers testing products and onboarding other quality engineering teams on the Red Hat continuous integration environment
Maintain and develop modules for the internal framework used for product interoperability and component testing, as well as create automated scenarios to execute tests at various levels (e.g. API, component, performance and integration)
Write, develop, and debug software and use automated testing tools
Participate in testing efforts with a group of local and remote engineers
Write code for new features and fix bugs for the internal frameworks used for product interoperability and component testing and an internal web dashboard application
Support internal customers for product interoperability testing, component testing frameworks, and web dashboard application
Attend meetings, understand requirements and plan internal releases
Work with the Continuous Integration team to understand new features and integrate them within product interoperability testing frameworks
Test, debug, and troubleshoot new versions of internal tools
Maintain documentation for product interoperability testing and component testing frameworks
Automate product installations and test execution
Conduct code reviews and provide assistance to other team members
Help create planning artifacts including schedules and test plans for new releases
Bachelor's degree (U.S. or foreign equivalent) in computer science, computer engineering, or a related technical discipline
5+ years of experience in the job offered or a job that required software testing
3+ years of experience on a Linux platform at the system administrator level
Experience with developing automation frameworks
Experience with software testing at the integration and system testing levels
Experience with standard software testing methodologies like ISTQB, as well as Agile and waterfall development models
Experience managing and using virtualized systems
Experience with formal bug tracking tools like Bugzilla or Jira, and automated testing tools like Selenium or Jmeter
Experience with code management process, including reviews, branch and release management
Experience with monitoring systems like Nagios, Opsview, or Zabbix, web development model view controller architecture, and object-oriented programming
Experience with Jenkins, Git, MYSQL, Xunit, Apache web-server, and Jquery

127

Senior Quality Engineer Resume Examples & Samples

Develop and monitor test plans
Actively improve Hybris’ software quality processes
Collaborate with business users, developers and other members of an agile development team
Computer science or related degree
5+ years of experience in testing (testing techniques)
Excellent knowledge in testing of medium to large scale software systems
Experienced in testing e-commerce software
Familiarity with agile development and testing methodologies
Basic knowledge of application deployment (for example ant, Maven)
Good Linux know-how
Development skills will be an advantage (writing scripts, xpath, css, understanding source code)
Excellent written and verbal English and local language skills
Ability to ensure work transparency and self-organize
Experience with work group tools (bug tracking systems, wiki)

128

Senior Quality Engineer, Learning Application Resume Examples & Samples

Analyze, design and develop test cases and implement automated test suites
Support continuous improvement with teams via tools, frameworks or processes
Coach, mentor, and cheerleaders for development teams
Plan, prioritize, validate software deliverables that meet functional and nonfunctional requirements
Participate in Scrum process, and effectively communicate progress, risk, and resolution
Participate discussion with stakeholders, including business partners, vendors, internal stakeholders, etc
Bachelor's degree in computer science or equivalent experience
5+ years of enterprise software development experience
3+ years of experience in test planning and test automation with the ability to implement automation using Java, JavaScript, Selenium/WebDriver, PL/SQL or comparable technologies
Solid Experience in Java and of Object-Oriented design
SQA methodologies (black box and white box testing)
Knowledge of SQL and understanding of relational databases
Knowledge of XML/WSDL, DOM, and other W3C standards
Experience with development tools, Jenkins. CI/CD tools, Git, etc
Experience with automation testing for integration, including REST and SOAP web services
Innovator with good ideas, strong problem-solving abilities, and a results-oriented attitude
Commitment to proper Software Engineering: Test Driven Development, Documentation, Code reviews, etc
Understand performance testing concepts
Force development experience covering core, APEX and Visualforce
Agile Scrum Process
Experience building Software as a Service (SaaS) applications
LY-I

129

Senior Quality Engineer / Performance Resume Examples & Samples

Provides technical expertise by independently determining and developing approaches to solutions for a wide range of complex software engineering problems. Assignments may include new products as well as upgrades, and enhancements or fixes to existing products
Contributes to the development and achievement of organizational goals and objectives
Represents the organization on project teams and may perform technical project leadership roles
Writes high level design specs, unit test plans and/or integration test plans
Analyze and code complex modules, define data structures, and specify test tools

130

Senior Quality Engineer Resume Examples & Samples

Bachelor’s degree in Engineering or scientific related field required
Master’s degree in Engineering or scientific related field preferred
Minimum five to seven years of experience in a cGMP manufacturing environment is required
Experience working in a FDA regulated operation conducting audits required
Experience working in cross-functional teams for both development and commercial manufacturing, involving launching commercial products and technology transfers required
Attention to technical detail and a strong understanding of manufacturing and or development processes required
Strong technical hands on understanding of pharmaceutical operations required
Working knowledge and experience of statistical analysis software (i.e. Minitab, Jump, SAS) required
Ability to prioritize and multi-task successfully in a fast paced environment
Excellent organizational skills with the ability to handle multiple tasks
Motivated and hard working
Must be able to work well independently and in a team environment
Must be dependable, flexible and available to work overtime and other shifts as needed
This position requires minimal travel; average travel for this position is 5-10% with some variation based upon the demands of the business imperative
Must be able to work in a controlled or clean room environment requiring special gowning as needed
Must have the ability to work safely and conscientiously in a manufacturing environment as needed
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

131

Senior Quality Engineer Resume Examples & Samples

Plan and schedule cross functional activities worldwide in different regions such as maturity level reviews, preparation for customer audits, etc
Coordinate and assure Harman quality requirements to customer
Conduct scheduled reviews with the appropriate process owners
Review all appropriate documentations, processes & results applicable, related to projects and if needed organize audits to get a visibility about the status
Contribute towards organizational process definition/updates
Bachelors Degree in Engineering related field
5-7+ years of experience in Automotive Quality and Program Management in similar programs
High level of understanding of Software development lifecycle and methodologies
Experience in leading customer escalations
Thorough knowledge of management systems, atleast one of CMMi or Automotive Spice. Other standards such as ISO/TS16949 are desirable
Excellent communication & interpersonal skills
Drive for Results, Team Player, Change Orientation, Customer Focus, Self Awareness
Seasoned professional in previous roles as a PM, Developer or Tester

132

Senior Quality Engineer Resume Examples & Samples

Test Software releases during the product development
Assist in Automation, develop automation scripts and execute them
Other responsibilities as assigned by the management from time to time
Proficient in Java
Hands on experience on Selenium Web driver
Knowledge on creating automation testing framework
Hands on experience in Continuous Integration tools like Jenkins
Hands on experience in working on Performance testing tool like Jmeter or any other such tools
Experience in Manual testing on Web Applications
Knowledge on API testing
Knowledge on SQL, GIT
Knowledge on Security testing
Must have minimum 5 years of working experience in testing mobile applications in reputed organizations
B.E / B.Tech or M.E / M.Tech / M.S. in Computer Science Engineering or an equivalent degree
Should have scored minimum 80% marks since 10 th Standard

133

Senior Quality Engineer Resume Examples & Samples

Position responsible for focusing on quality procedures and processes
Quality Management and Standardized Work applications
Required to support monitoring Quality policies and procedures, data collection supporting Quality performance targets and subsequent analysis of data to measure against established performance goals
ISO Controller, internal audit
Support on-site Quality visits or assessments to quantify data collection plans as deemed necessary and applicable
Implements a continuous improvement culture through the use of Six Sigma methodologies by applying the appropriate defect preventions tools to ensure quality improvements
Support quality relationships with all customers in relation to quality of products and services with alignment to the Commodity Directors
Support resolving Quality issues and ensure that Closed Loop Corrective Action is implemented
Leads projects related to Quality supported by cross functional teams
Provides analysis on data collected to support an analytical decision process
Technical assistance to Manufacturing/Engineering/QA on procured items and modules from supply line process perspective
Offers subject matter expertise that contributes to the development and implementation of policies and procedures
Actively works on and is engaged in complex Quality-related projects, problems, issues, or opportunities which require in-depth evaluation across multiple disciplines
Analysis of supplier performance evaluation data; Use of metrics to drive process improvements
Supports procurement relationships with key suppliers in relation to quality and delivery of products and services
Leads and provides independent assessment of process and product quality and escalate issues/concerns when needed to ensure the quality of the solution provided to the customer
7+ years of experience in Quality
Experience in management/supervisory/leadership
Bachelor’s degree in Electrical Engineering/Master’s Degree in Quality is desirable
ISO and Six Sigma certification
Knowledge of QMS (Quality Mgmt. system), TQM (Total Quality Mgmt.), ASQ (American Society of Quality)
Process Engineering and Program Management skills
Proven leadership ability in supervisory roles, communications, and solutions development
Strong quantitative, analytical and systems thinking skills
Excellent consulting, coaching, and team building skills

134

Senior Quality Engineer Resume Examples & Samples

Ensure compliance of design control and design change activities through the review and acceptance of design activities independently of the New Product Development (NPD) design team
Ensure that Design History Files and other associated quality documentation are complete and compliant by means of review and approval
Work with New Product Delivery (NPD) teams to ensure verification and validation outputs meet design inputs through the creation-review-execution of test cases and participation in product risk analyses and change reviews
Provide support to Operations and Downstream QA teams to ensure successful transfer of the design and design controls to manufacturing, in accordance with all applicable regulations
Assist in the adoption of test methods, equipment acquisition for product testing, validations/qualifications, statistical analysis of data for significance and other requirements through review and approval of protocols and reports
Review and approve development specifications, including those for raw materials, intermediate products and finished products
Maintain currency of knowledge required to carry out the essential duties and responsibilities effectively
To apply high standards of occupational Health & Safety in the workplace to comply with company policy and procedures
Holds a professional scientific qualification e.g. B.Sc. Hons Electro-Mechanical / Electrical/ Manufacturing Engineering or equivalent based degree with a minimum of 2:2 classification result and above
The role is pivotal in ensuring that scientific and analytical information is provided to support quality, product safety, design control, marketing support activities and the quality/shelf life of products in order to ensure that the projects are successful
Successful individual will be able to work independently and be comfortable not being micro-managed but also work collaboratively across different areas
Medical devices product knowledge is key and having worked within a similar industry sector now or in the earlier stages of one’s career is also key
Technical knowledge around medical devices is also key coupled with strong communication, mentoring and coaching skills as this role may eventually involve supervising more graduate level team members
A nice to have would be to be a trained Lead Auditor but not essential here

135

Senior Quality Engineer Resume Examples & Samples

1) Statistical Analysis using DOE, GR&R, Capability Analysis, MiniTAB, analysis of variance; sampling theory and factor analysis
2) Problem solving skills including root cause analysis/ corrective & preventive action/ FMEA (failure mode and effect analysis)
3) ASQ CQE and CQA certifications
4) Conducting quality audits using ISO 9001/ ISO 13485/ FDA QSR 21 CFR Part 820
5) Geometric dimensioning & tolerance

136

Senior Quality Engineer Resume Examples & Samples

Be a leader of SSG Quality Business Systems upgrades from ISO9001-2008 to AS9100D to focus on consistently meeting customer requirements and enhancing their satisfaction. The successful system will be aligned with company's purpose and strategic direction
Champion and manage internal and externally driven audit program, by performing and leading risk-based operational audits and performance audits which require a broad array of competencies
Lead enterprise corrective action system and manage closure of corrective actions
Champion Quality System continuous improvement, process excellence, process improvement, process measurement with a risk based focus
Lead process deployment associated with AS9100D
Manage ongoing AS9100D system, associated continued process improvements and registrar interactions
Be a focal point for SSG customer quality perception and company customer satisfaction measurements
Drive resolution of issues potentially impacting mission success by working with program teams, and customers
A Bachelor’s of Science degree in Engineering or the equivalent. An advanced degree or MBA is preferred
Minimum 10+ years of quality assurance experience with a focus on system deployment and management for company(s) involved in the design, development and manufacturing of complex systems with a preference for experience with sophisticated space based electro-optical systems
Extensive knowledge of specifications and standards for aerospace equipment and quality programs is required including knowledge of AS9100 and ISO9001
ISO9001-2008 Course Completion
RABQSA Certified
SAE Courses Changes in AS9100C, AS9100D, Understanding AS9100C
IAQG Sectioned Training with Aerospace Auditor Transition Training
Lean and Six Sigma certification, training and background
Excellent written and presentation skills with the ability to clearly and competently convey mission assurance requirements and execution strategies to the program team
Strong interpersonal and influencing skills with the ability to work as an individual contributor and as a team leader in a cross-functional team environment
Strong business acumen with the ability to work with customers and suppliers

137

Senior Quality Engineer Resume Examples & Samples

Work with the complete Red Hat JBoss Middleware solutions portfolio and make sure our solutions are cloud-enabled
Develop and automate small integration applications that verify features and operation of individual system components
Specify product requirements needed to be competitive in the market
Contribute bug fixes to upstream
Develop sample applications and quickstarts
Java SE/EE expertise
Experience with Red Hat JBoss Middleware is a plus
Passion for open source technologies
Familiarity with software development methodologies

138

Senior Quality Engineer Resume Examples & Samples

Ensure areas of responsibility meet FDA 21 CFR 820 and ISO 13485 requirements
Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely manner
Provide recommendations for business process improvements as they are identified during the analysis, tracking, and trending of quality review inputs
10+ years’ experience in quality management systems
Strong knowledge and experience with quality regulations and standards as well as experience applying them (e.g., 21 CFR 820, ISO 13485, ISO 14971)

139

Senior Quality Engineer Resume Examples & Samples

Support process validation studies for special processes to improve TE-Medical's quality assurance methodology. Support development of Product Validation Plans, IQ/OQ/PQ protocols, and Test Measurement Validations
Resolve any special quality, test, and certification requirements in cooperation with engineering and assure overall agreement between TE-Medical and customer drawings and specifications
Draft and execute design of experiments (DOE) and capability studies
Work as a part of a core team with Development and Manufacturing Engineering as required in new product introduction. Contribute to all new product deliverables, including Design and Process FMEA, Control Plans, etc
Work to affect Cost of Quality improvement projects
Work with Manufacturing Engineering in the day-to-day identification & resolution of production issues
Drive to resolve product return and customer complaint issues
Support the new product develop processes to assure product meets customer requirements
Provide leadership to and be a capable resource for the development of and execution of statistical process control (and appropriate related methods)
Support and manage the verification system at TE-Medical for new and existing products. Support 1st Article inspection program, process capability studies, and inspection audits to verify quality levels for problem P/Ns
Develop standard quality inspection procedures and methods
Promote compliance to company procedures
Five or more years of experience in quality engineering
BS degree in science, engineering, or manufacturing
Demonstrated expertise in quality concepts, practices and procedures
Strong interpersonal skills are required
Ability to plan, establish and coordinate test and inspection procedures, conduct process capability studies, prepare statistical quality control data and develop statistical designed experiments
Knowledge of FDA 21 CFR Part 820 and ISO 9001 or 13485
Ability to travel as necessary

140

Senior Quality Engineer Resume Examples & Samples

A minimum of a Bachelor’s degree in Engineering is required. A Bachelor’s degree in Mechanical Engineering or a Master’s degree is highly preferred
At least five (5) years of experience in validation supporting Product/Process and/or Quality Engineering in a manufacturing regulated environment is required
Knowledge of 3-D Computer Aided Design (CAD) tools and programming languages is required
Must have basic knowledge of Geometric Dimensioning and Tolerance (GD&T) and the ability to understand, explain and challenge Engineering drawings
Must have knowledge of validation related regulations
ASQ Quality Engineer certification is preferred
Engineer in Training (EIT) or Professional Engineer (PE) Licenses are preferred
Proficiency in Microsoft Office programs (Word, Excel, Outlook, and PowerPoint) is required
Must be fully bilingual (English/Spanish, read, write and speak)
This position may require up to 15% domestic and international travel

141

Senior Quality Engineer Product Software Development Resume Examples & Samples

Ensure products are developed and maintained in accordance with applicable industry standards and regulations
Maintaining the QMS with regards to current applicable standards and regulations
Corrective actions investigations
Quality Training
Travel to Philippsburg (Germany) will be required, 15%
International travel may be required, around 1 trip per year
A minimum of 3-5 years’ experience in a regulated industry in quality assurance, new product development, or manufacturing engineering
Experience in the Medical Devices Industry is a must

142

Senior Quality Engineer Resume Examples & Samples

Research, develop, and implement test automation tools and frameworks to enable a high degree of test automation
Develop and execute functional, integration, usability and performance tests
Analyze and prioritize the quality risks posed by product in development and determine the tests required to mitigate these risks
Clearly document new bugs and advocate their resolution with developers, as well as communicate their impact on customers and their businesses
Collaborate with software developers, as well as support and documentation teams
University education in IT (bachelor’s or master’s degree), or equivalent work experience
Experience with Java SE and JavaEE development
Knowledge of build systems (Maven, Gradle) and version control systems (Git)
Experience with test development (JUnit, TestNG)
Experience with an IDE (Eclipse, IntelliJ, NetBeans)
Experience with GUI testing and tools such as Red Deer, SWTBot, or Selenium is a plus
Experience with testing REST endpoints is a plus
Experience with DevOps and continuous delivery is a great advantage
English communication skills and ability to read technical documentation

143

Senior Quality Engineer Resume Examples & Samples

Provide Quality Assurance support for composite laminate & composite co-bonded assemblies fabrication
Quality Assurance duties include, but are not limited to: in process inspections as defined in the MWIs and step stamps; part visual inspections per post process inspection for laminated parts requirements; parts thickness inspection; part contour to tool surface inspection per panel contour conformance requirements
Quality assurance shall also coordinate with LM NDE and dimensional inspectors to verify parts & assemblies are satisfactory: laminate defect criteria and assembly Pi-preform bond defect criteria; dimensional requirements per engineering drawings
Quality Assurance shall record the anomaly or non-conformance within 24 hours of detection. Quality Assurance shall support the material review board to safe the hardware; preserve the relevant data; investigate the root cause; recover from the anomalous condition; coordinate disposition instructions fro the hardware, and implement corrective & preventative actions

144

Senior Quality Engineer Resume Examples & Samples

A minimum of a bachelor’s degree in Engineering is required
At least two (2) years of experience in World Class, Quality Assurance Engineering or Technical field within a regulated manufacturing environment is required. Experience in the Medical Devices industry is highly preferred
Working knowledge of process validation, test method validation and applied statistics is required. Must have knowledge of Quality System Regulations and ISO 9000
Must have proven track record of appropriate training and knowledge on statistical technique competencies
Project management and/or Six Sigma (Black or Green Belt) certifications are highly preferred
Engineer in Training (EIT) or Professional Engineer (PE) License is preferred
Proficiency in Microsoft Office programs (Word, Excel, Outlook, and PowerPoint) is required. Experience working with Minitab is preferred
Fully Bilingual (English and Spanish, oral and written) is required
This position may require up to ten percent (10%) of domestic and international travel

145

Senior Quality Engineer Resume Examples & Samples

Bachelor's degree (Software/Computer Sciences, Industrial Engineering, Geosciences, Management) and work experience of min. 5 years in a quality management and assurance role or HERE company processes
2-3 years of experience in working with, and setting up Quality Management Systems according to ISO 9001 and/or ISO/TS 16949
Experience with software development methods (e.g. Agile) and a software continuous improvement framework (e.g. CMMI, A-SPICE) will be an added advantage
Software Process engineering and Software Quality Assurance experience is a plus
Experience in Continuous Improvement/Lean Manufacturing techniques (i.e. 5s, Kaizen, Value Stream Mapping) is highly desirable
Ability to motivate team members in a multi-cultural environment
Excellent oral, written communication and presentation skills
Statistical background is a distinct advantage
Highly computer literate (MS Office, Visio, Project, etc.)

146

Senior Quality Engineer Resume Examples & Samples

7+ years of software test experience
Passion for producing quality work
Media software

147

Senior Quality Engineer Resume Examples & Samples

Participates on Project Team as Quality Representative. Ensures that principals of Design Control are applied to Product and Process Changes and New Product Development
Provides Quality Assurance leadership for Project Teams or Quality Department
Creates, reviews and approves Quality System Documents (CAPA, Audits)
Creates, reviews and approves Product Documents
Creates, reviews, and approves Protocols, Process and Product Validations, Stability Protocols, Software Validation documents
Mentors entry point staff
Provides supervision to technicians and engineers
Assists in the review and interviews of potential candidates
Creates, reviews and approves documents required for Design History File
Creates, reviews and approves Risk Assessments such as FMEA, FMECA or FTA
Performs Internal or Supplier Quality System Audits
Participates and has membership in trade and/or professional organizations to ensure that state-of-the-art industry standards are communicated into the division in an efficient, timely, and accurate manner
Tracks and trends Quality Indicators
Serves as Independent QA Reviewer and Chairperson for Design Reviews
Ability to perform engineering work of a broad nature with little or no direction from Quality Management. Generally, receives guidance on novel or controversial problems. Extensive knowledge of medical device regulation, industry or international standard, including management responsibility. Ability to understand Division and Plant Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency. Ability to interface with regulatory bodies to present technical information. Comprehensive knowledge of quality systems and relationship to business. Has experience in writing process, software, and equipment protocols/validations and has fundamental knowledge of validation principles. Understands basic applied statistics, statistical sampling plans, and statistical process control and advanced statistical methodologies such as DOE and Taguchi. Ability to serve in leadership roles on projects or assignments. Comprehensive understanding of auditing principles and ability to perform as a lead auditor. Ability to participate and provide leadership on teams and maintain positive work environment with those teams. Understands team functions, leadership techniques and project management methodologies. Broad knowledge of manufacturing processes. Excellent communication skills (verbal, written, and presentation). Understands how to present information dependent upon the level of the audience. Understands Fundamentals of Engineering Principles. Ability to effectively manage time. Ability to handle multiple task assignments. Ability to translate quality requirements into product specifications. Ability to interpret Regulations, Corporate, Division and Department Procedures
B.S. in Engineering, Engineering Technology, Science a minimum
American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.)
Minimum 4 years of experience with FDA regulated industry including three years on product development programs

148

Senior Quality Engineer Resume Examples & Samples

Carry out manual tests and deliver clear status for testing areas in a timely manner
Communicate with other OpenShift by Red Hat quality engineers and developers in English
Work in a fast-paced environment
Test experience working with globally distributed QE team members
5+ years of experience in quality engineering
Knowledge of the UNIX or Linux operating system (any distribution)
Programming language skills in Bash, shell, and Java
Programming language skills in Go, Ruby, or Python
Dedicated to learning and collaboration
Knowledge of virtualization, Red Hat JBoss Middleware, container technology, kubernets, Red Hat CloudForms, Red Hat OpenStack Platform, or OpenShift is an advantage
Contributions to open source projects or publicly available code samples is a plus

149

Senior Quality Engineer Resume Examples & Samples

Develops and initiates standards and methods for inspection, testing and evaluation
Devises sampling procedures and designs and develops forms and instructions for recording, evaluating and reporting quality and reliability data
Directs workers engaged in measuring and testing product and tabulating data concerning materials, product or process quality and reliability
Supports Product Engineers and Quality Program Managers with customer interfaces as necessary on quality related issues
Assures data availability and integrity for all quality related data. Consolidates and reports quality results
Initiates corrective action requests as needed and tracks to satisfactory completion
Assists with development and implementation of quality audits
Responsible for developing, applying, revising and maintaining quality standards for processing materials into partially finished or finished products
Establishes program to evaluate precision and accuracy of production equipment and testing, measurement and analytical equipment and facilities
Provides liaison to various regulatory bodies
Bachelors degree and 5 years of relevant quality engineering experience
Prior knowledge or experience with multek products
Knowledge of Baan or similar ERP
Knowledge of technical writing procedures

150

Senior Quality Engineer Resume Examples & Samples

Research the product architecture
Design threat modeling for the product
Prepare test plan and test cases for any identified threat, vulnerabilities or security risks
Identify proper necessary security test tool to facilitate security testing
Perform security testing execution, report security bugs, and perform security bugs verification
Conduct security code review
Prepare security testing result report
Communicate with multiple teams including Development, QE, and other related teams within Red Hat
Bachelor's degree or higher in computer science or related program, or equivalent relevant work experience
4+ years of experience in quality engineering focus on security testing
Solid knowledge and understanding of Linux operating system
Solid knowledge and understanding of common security vulnerabilities
Solid knowledge and understanding of security, network, operation system, web, database etc
Experience with or the ability to learn security testing tools like openvas, nikto, tcpdump, wireshark, metasploit etc
Experience with or the ability to learn Go and/or Ruby programming language quickly
Experience with or the ability to learn Container Technologies, Kubernetes, OpenShift quickly
Contributions to open source projects or publicly available code samples would be a strong plus/consideration
Good written and verbal English language/communication skills

151

E-powertrain Senior Quality Engineer Resume Examples & Samples

Responsible for management of repair center, including shipping/receiving all battery packs that are returned from Pontiac warehouse/ GM plant / Warranty return, analyzing, root causing, problem solving and repair/refurbish the defective packs and validation with EOL test equipment. And manage technician’s operation and training
Manage spare parts in stock for repair/refurbish
Participate in the development of Failure Mode and Effects Analysis
Effectively communication with customer and internal communication of quality issues
Prepares reports by collecting, analyzing, and summarizing data; making recommendations
Technical Knowledge of automotive electronics

152

Senior Quality Engineer Resume Examples & Samples

ISO/AS Lead Auditor certification a plus
SAP, PMEMS, Agile, and Team Center knowledge a plus
Experience with Optics and Wafer Fabrication a preferred
Experience with Quality Assurance systems such as AS9100 Rev D, and ISO9001:2015 a bonus

153

Senior Quality Engineer Resume Examples & Samples

Own test strategy and execution that directly impacts the customer experience
Write test plans by partnering with business stakeholders to define expected outcomes and goals
Automate test scripts by implementing test frameworks and technologies
Identify critical defects and work with engineering team to troubleshoot issues
Ensure accuracy, reliability, and scalability while accelerating the product development lifecycle

154

Senior Quality Engineer Resume Examples & Samples

Lead an agile team by driving user story analysis and elaboration, designing and developing software applications, and testing and building automation tools
Create and maintain automated tests running in a continuous integration environment
Ensure excellent application usability through careful manual testing
Contribute to designing test cases and testing in ongoing sprints
Self motivated and able to independently learn new technologies
Analyze and create end point mocks to aid in testing
5+ years of technical experience in a software development organization with a Bachelor’s or Master’s Degree in Science (preferably Computer Science, Engineering or other related disciplines)
Has exposure to a variety of distributed infrastructure technologies and systems
Eagerness to work iteratively and collaboratively to build new software
Excellent bidirectional communication skills
Deals well with ambiguous/under defined problems; able to think abstractly

155

Senior Quality Engineer Analyst Resume Examples & Samples

Execute automated and manual test scripts and appropriately record results
Record defects in defect tracking system and follow-up on corrections
Perform basic root cause analysis to analyze defects with developers, analysts and customers
Work in Automation group to assist with identifying and automating tests
Develop/execute automated test cases
Write new test cases and maintain automation test library
Write Test Plans
Understand Framework and continuous integration of applications
Knowledge of automation testing to assist with automating manual test cases
Working knowledge of Selenium WebDriver
Working knowledge of the Java Programming Language is a plus
Working experience with Quality Center is a plus
Basic knowledge of Asset Management or other ERP Concept and Tools

156

Senior Quality Engineer Resume Examples & Samples

Deputise for the HAY Quality Manager regarding all Quality Assurance activities and functional requirements including representation at Leadership level and management reporting
Interface with regulatory bodies / customers and stake holders representing HAY at all levels ensuring positive outcomes for the organisation and its customers / stake holders
Tactical operation of the Quality Management System to ensure it is developed, maintained, understood and executed by all associates, with special emphasis on product and processes in accordance with European Aviation Safety Agency, (EASA Part 21), Military Approval requirements and AS9100 including Customer or any other regulatory requirements as necessary
Promote and utilizing enablers such as Honeywell Operating Systems (HOS) including Built in Quality identifying best practices driving continuous Quality improvements throughout the organisation using Kaizan, RPS / FMEA and other improvement tools
Lead the development and execution of the internal audit program including customer, regulatory audits to measure the overall effectiveness of the Quality Management System including operation of the eCATS System and customer related data systems with supervisory responsibilities for other audit personnel
Tactical organisation of Quality / Technical / Regulatory training for all HAY associates in compliance with Honeywell, Customer and Regulatory requirements
Ensure customer satisfaction through direct customer contact ensuring improvements in communication and customer compliance
Support for the review of contractual Quality requirements to ensure compliance to Honeywell, Customer, EASA / Military or other regulatory requirements
Responsible for authorisation of Quality Assurance related documentation and process approval, as directed by the Quality Manager, both functionally and on behalf of HAY
Support and execute projects leading to AERO / HAY standardisation, simplifying and improving existing Quality Assurance processes ensuring compliance with Honeywell AERO & Regulatory requirements
Assistance for R&O activities undertaken at the HAY Site by Honeywell Aerospace Bournemouth including the development of R&O regulatory requirements within HAY
Promote and support Health, Safety and Environment (HS&E) activities and initiative
Manage the Supplier Audit Schedule and conduct Quality system Audits as per Site procedures
Support all Customer & Regulatory audits for Supplier Quality / Supply Base Controls, presentation of material & data as required and close out any NC's or Observations as applicable
Responsible for coordinating the Supplier Quality Profiles compliance for the site in line with Site procedures
Relevant degree or experience in a technical field with emphasis on Quality Assurance systems
Quality in a related aerospace environment will be considered
Lead Auditor Qualifications
Six Sigma Greenbelt, or equivalent, is required, Blackbelt preferred with emphasis on Lean / Change management
Excellent knowledge of CAA/ EASA Part 21/Part 145 / AS9100 Regulations with emphasis on Production Organizations
Proven Customer experience, with solid understanding of Quality Assurance Systems
Must have Leadership skills and the ability to team work
Excellent interpersonal skills coaching & mentoring
Ability to manage multiple projects and changing priorities while working effectively in a team environment
Ability to communicate ideas with clear understanding of audience and gain commitments that are critical to the success of the organisation

157

Senior Quality Engineer Resume Examples & Samples

Responsible for failure analysis of OmniVision Image and issue failure analysis reports for customer failures
Assure quality throughout the product life cycle: product development, manufacturing, failure analysis, production releases; and servicing
Drive and improve product, test, and quality processes
Lead quality improvement initiatives, implement proactive actions to reduce test quality incidents
The candidate will be required to assist with the analysis of customer returns and generating technical reports for internal and external consumption
Drive customer problem analysis, corrective actions, and issue reports
Improve customer processes and advocate test quality in the context of end-user satisfaction
Drive internal Quality improvement activities such as design, test and supplier quality
5+ years of experience in Product, Quality or Test engineering in semiconductor industry (Knowledge of image sensor testing and quality is a plus)
Good understanding and experience of Electrical failure analysis of electronic component/module testing
Dynamic, progressive, proactive, responsive, and hands-on experience and ability to work in multi-functional teams with minimum supervision
Strong interpersonal and communication skills, flexibility, team spirit, and positive approach
Proficient in problem solving, report writing, and follow through
BS degree in Electrical or Computer Engineering
MS degree preferred

158

Senior Quality Engineer Resume Examples & Samples

Support all plant health and safety efforts. Ensure that activities are constantly being reviewed for safety and MESH compliance. Provide Safety Coaching as required
Ensure compliance to ISO/EQS (Eaton Quality System) and lead efforts to continually improve how it is applied throughout the facility
Organize and lead the plant MRB functions, support team by reading and interpreting engineering prints, engineering specifications, and utilization of Geometric Dimensioning and Tolerancing (GD&T)
Drive efforts to reduce scrap and non-conformances. Monitor and trend non-conforming data and review/share with operators, staff and others
Provide and post as necessary (Daily, monthly, Weekly) key plant data such as MRB Health, DPPM Non-Conforming and CPAR Status
Drive plant wide CPAR activities (8D, A3 and other methods)
Lead APQP activities for Suppliers. Owns and manages the PPAP process for the facility
Drive plant preventative actions (PFMEA, Control Plans and MSA) Support the plant in the development of key process PFMEA’s and Control Plans. Support manufacturing by performing Measurement Systems Analysis (MSA) in order to identify and eliminate measurement errors and ensure the correct gages are being employed throughout the plant
Support the efforts to maintain and develop standard work throughout the plant
Leads and assists in internal/external ISO/EQS audits
Support utilization of the WISPER supplier management intranet site as it relates to receiving inspection. Assist in the definition and guidance of supplier development activities to ensure suppliers are meeting or exceeding expectations
Actively participates as a member of PROLaunch New Product Development teams, representing plant quality functions
Act as Quality Lead for Change Control
Actively participate as a member of PROLaunch New Product Development teams, representing both plant and supplier quality functions
Participate and support all Continuous Improvement and Lean activities as necessary
Identify opportunities to drive cost out of the organization through improvements, both internally and with supply base
Drive the company’s vision and mission by reinforcing ethics, values and quality policies throughout their area of responsibility
Actively participate in setting, communicating and achieving Plant goals and objectives
Actively lead and participate in the Eaton Quality System (EQS)
Develop and maintain performance metrics as required to monitor results and uses as a tool to identify and initiate process improvements within the manufacturing facility
Possess analytical skills and understanding of problem solving tools/methods; Possess excellent communication and interpersonal skills
Coordinate and leverage resources, such as maintenance, materials, scheduling, logistics and engineering, to resolve quality issues and/or improve processes
Apply appropriate Eaton Quality System (EQS) processes and problem solving tools to drive continuous quality improvement and ensure alignment/compliance with industry standards
Constructively interact with internal customers
Promote a quality culture by demonstrating customer focus. Regularly communicate customer feedback to employees in order to facilitate collaborative problem solving
Requires knowledge of quality methods and systems and the ability to read and interpret engineering drawings and specifications
Strong written and verbal communication skills including computer skills with proficiency in Microsoft Office applications
Bachelor’s degree from an accredited Institution
Minimum 1 year experience in the field of Quality in a manufacturing plant environment required
Must reside within 50 miles of Brooklyn, OH
ASQ Certification (CQE, CQA, CQM, etc…)
Experience in deploying Lean/Continuous Improvement in a high mix, low volume environment is preferred
Experience with PFMEA and Control Plan for process improvements is preferred

159

Senior Quality Engineer Resume Examples & Samples

Act as the Manufacturing Lead with respect to the thorough investigation of Non-Conforming Materials and Complaints, using Data Analysis/Problem Solving Techniques to arrive at Root Cause and identify Corrective & Preventative Actions to prevent recurrence
Process Audits of the manufacturing lines to ensure the product being manufactured complies with all requirements, and that the Equipment/Process in use complies with the relevant EXPS (Set-Up Sheets) and Standard Operating Procedures
Identify and suggest improvements to current equipment, processes, and procedures to streamline the manufacturing activities while ensuring high standards of quality

160

Senior Quality Engineer Resume Examples & Samples

Ability to effectively communicate in English
Minimum of 2 years of experience in leading CAPAs
Working knowledge with CAPA systems
Strong understanding of the medical device and pharmaceutical quality system regulations and industry standards

161

Senior Quality Engineer Resume Examples & Samples

7 or more years in Supply-Chain Quality or Manufacturing Quality
Knowledge of aerospace quality standards including AS9100, AS9102, & ISO
Demonstrated ability to interface with all levels of management, external customers, and government agencies

162

Senior Quality Engineer Resume Examples & Samples

Creating annual process deployment plan and drive the plan
Collaborate with SBU leadership and ACT leadership
Support CMMI appraisal and NPI process deployment
Define product development processes to meet business and CMMI expectations
Perform audits and appraisal; drive process improvements
Assess the projects on a maturity model framework
Experience in planning and conducting appraisals
Strong understanding of different product development life-cycle Models – Waterfall, Iterative, Agile
Development and maintain Process assets & databases
Knowledge of statistical tools for data collection and metrics analysis
Perform analysis of metrics, audit results and lessons learned and report those out to senior management
Certified Quality Analyst, CSM, Green Belt/Black Belt Trained / Certified will be an added advantage
At least 2 years experience in engineering roles of software development
At least 2 years working with Global teams/customers
Good team player

163

Senior Quality Engineer Resume Examples & Samples

Monitor all FGQA quality assurance functions
Provide QS support in Product transfers and new products development
Assist in training new engineers, train technicians and supervisors in process changes
Participate in process/ quality improvement projects
Support COGs initiatives
Follow J&J and EES Records Management Policies for Convenience Information, Records Retention Schedules, Training and Education, Document Hold Notices, Records Cleanout,
Assist, review & approve non-conformances investigations & non-conforming product dispositions
Provide as needed, subject matter expert feedback on manufacturing process changes
PC experience

164

Senior Quality Engineer Resume Examples & Samples

Provide technical leadership and quality perspective on design assurance requirements and activities for project teams developing electro-mechanical medical device products to be sold worldwide
Develop key Design Control deliverables (FMEA's, Design and Project Plan, Quality Control Plan)
Work with External Manufacturers (Quality Control Plan, Supplier Quality, Product Returns, and Investigations)
Implement Risk planning, assessments, analysis, and reduction including mistake proofing
Support equipment and process validation (First Article, TFIQ, IQ/OQ, TMV, SW, PQ and PPQ), process monitoring and controls
Provide QE support on root cause analysis for complaints, CAPA and other quality related investigations
Activities would include: Quality Planning, Analysis of System and Hardware Requirements, Verification and Validation Planning, Risk Assessment/Analysis, Review of Test Protocols, Technical Design Reviews, Disposition of Test Observations, and providing input to the Quality System and its processes
Minimum of four years of experience in design control, design verification and validation, and risk management
Bachelor's degree in biomedical, electrical or mechanical engineering or related discipline
Experience with Medical Device Manufacturing
Experience in Design Reviews and managing Design History Files
In-depth Root Cause analysis, technical writing skills
Robust statistical skills and analytical thinking
Strong time management skills, good documentation practices and communication skills
Knowledge of quality assurance practices within the medical device industry, including FDA Quality System Requirements (QSR) and ISO 13485
Excellent English written and verbal communication skills
Able to influence and work with large cross functional teams
Take initiative and have the ability to conduct hands-on work
Ability to handle multiple tasks with high attention to detail

165

Senior Quality Engineer / Professional Resume Examples & Samples

Quality System Compliance - Demonstrates good; general understanding of the standards and regulatory bodies that regulate our industry
Leverage experience with integrated hardware/software systems to provide quality systems guidance to the technical team throughout the product development process
Apply appropriate configuration management principles throughout the iterative stages of design and development
Communicate quality goals and issues with technical and supporting team members, as well as management

166

Senior Quality Engineer Resume Examples & Samples

Experience with testing large-scale storage systems and applications
Strong understanding of enterprise datacenter architectures (physical and virtual servers, SAN, NAS, networking, etc.)
Experience configuration, and deploying servers, storage devices, operating systems and other software to run simulations and tests
Experience with multiple operating systems, including Linux, Solaris, and Windows·
Experience with virtualization and cloud-computing products, including VMware, OVM, and Openstack
Experience designing, deploying and troubleshooting networks
Experience in writing software using an object-oriented language such as Python or C++

167

Senior Quality Engineer Resume Examples & Samples

Provide guidance and oversight to Manufacturing Engineers and Technicians on procedural readiness execution and remediation. Measuring execution and effectiveness
Track and ensure all quality improvement actions and projects in the area
Monthly reporting on quality improvement activities
Lead Quality Improvement projects (initiating Change Request / Change Order as necessary and overseeing the change was implemented and sustainable)
Support to Investigations Engineers
Provide guidance and oversight to Manufacturing Engineers on changes that can result in Mix up, labeling, pouching or other risks related to line layout and material flows
Quality liaison for line support engineering team
Executes and/or Reviews Rework and Yield Evaluations performed by Line Support
Responsible for completing CR QE Impact Assessments and ensuring a thorough impact assessment is performed by all functions for the proposed change
Responsible for reviewing / approving CO’s requiring QE approval
Responsible for providing support during internal and external audits
Leads Line Support team in making changes as appropriate on the line to aid in compliance and productivity assurance
Works towards preventing/eliminating NCR's, yield issues and productivity barriers
Identify, evaluate and implement MFG/QA procedures to ensure the quality of products
Create a culture of positive engagement on the line
Minimum of 6 years of relevant experience in Quality and/or Compliance, preferably in medical device industry
Knowledge of applicable US & non-US applicable regulations
Knowledge and proficiency in the application and principles of Quality Engineering
Ability to effectively communicate cross-functionally to lead in resolving Quality issues
Ability to lead complex processes
Ability to interact effectively with all levels of employees
Ability to work with multiple priorities in a dynamic work environment
Ability to manage difficult situations and make timely effective decisions under

168

Senior Quality Engineer Resume Examples & Samples

Devise strategies to test from product specification and develop test plans, test design and automation to cover various layers of the online service, UI, desktop Apps
Continuously apply innovation to deliver high quality products to customers
Leverage our tools and infrastructure to develop end to end test automation to support the release life span
Establish release criteria and metrics to ensure outstanding product quality
Evangelize the adoption of new tools and practices to improve quality and efficiency
Report product defects and collaborate with Dev in resolution
Bachelors or higher degree in Computer Science and/or Electrical Engineering degree
Minimum 5 years of experience developing or testing commercial software
Strong test case development skills
Proficiency in one or more of the following programming languages: Go, Java, Python, C++
Familiarity with continuous integration software such as Jenkins/Hudson or Drone
Experienced with virtualization software - VMware, virtualbox, citrix, kvm
Broad technical knowledge including operating system fundamentals (task scheduling, memory management) and systems administration (installing and configuring operating systems and hardware)
A strong attention to detail and a feeling of pride and ownership over the quality of our product
Ability to work independently with minimum supervision as well as work in a team
Ability to drive initiatives across functional teams
71407BR

169

Senior Quality Engineer Resume Examples & Samples

Drive Defective Parts per Million (DPPM) reduction by leading cause analysis for process/product variability and driving quality improvements for elimination of special causes and reduction of variability
Apply a working knowledge of quality principles and statistics to assigned processes and products
Lead effective root cause analysis / corrective action through use of cause mapping, process mapping, fishbone diagrams, etc
Develop test methods
Effectively identify, troubleshoot and resolve non-routine problems
Serving as resolution owner for incoming customer complaints, including identifying root cause and implementing effective corrective actions
Ability to lead continuous improvement efforts in any of the IATD Business Units, which may include the following
Quality system improvement projects that will enable our production operations to continuously run to target, reduce variability, and consistently produce quality products for our customers
Product & process improvement projects
Supplier improvement projects
Provide Quality Engineering support to New Product Introduction (NPI) teams
Manage documentation, including Customer Certification & Test Instructions (CTI’s), Production Parts Approval Process (PPAP’s), DPPM reports, Advance Change Notices, customer surveys, etc
Minimum of one (1) year combined experience in Quality and/or Product Engineering
Bachelor’s degree or higher in a Science or Engineering discipline from an accredited institution
Quality Engineer (CQE) certification from the American Society for Quality (ASQ)
Lean Six Sigma (LSS) trained
Experience as a Quality Systems Auditor and/or Quality Engineer
Experience with statistical tools to guide decisions
Ability to assess risk and prioritize
Strong verbal and written communication skills with the ability to influence across all levels

170

Senior Quality Engineer Resume Examples & Samples

Develop and maintain automation testing framework (Python); write and review patches on GitHub and Gerrit
Research and implement new APIs and features to be automated
Execute, review, and debug existing test results and fix the problems
Develop and maintain CI/CD tools
Bachelor's degree with 7+ years of work experience OR master's degree with 5+ years of work experience
3+ years of experience and skills with Linux
3+ years of work experience in software testing or development
Work experience in virtualization is a plus
Solid scripting skills and 3+ years of experience with Python; Bash or Perl skills are an advantage
Familiarity with a wide variety of components of virtualization (KVM, XEN, or libvirt tools)
Motivated with an ability to work under pressure

171

Senior Quality Engineer Resume Examples & Samples

Develop, implement and maintain Statistical Process Control techniques
Conduct investigations to determine causes of defects, make recommendations for corrective action
Monitor and revise quality documentation as required
This role will also manage the Quality Lab and technicians
Minimum of two (2) years automotive experience

172

Senior Quality Engineer Resume Examples & Samples

Define/review quality requirements for the product life-cycle oriented industrialization of RRPs and related suppliers as well as third party manufacturers of electro-mechanical devices and components
Provide direction & support towards the industrialization teams as well as the suppliers to ensure that the defined quality requirements are met while short, mid and long-term QA strategies of the respective suppliers are aligned with the overall commercialization plans of RRPs
Build and maintain knowledge on quality practices around the related manufacturing processes and closely support product quality and productivity improvement initiatives
Lead/coordinate product and supplier qualifications (including audits) through close collaboration with multi-disciplinary teams including business entities such as procurement as well as technical functions such as product development
Provide technical guidance & support for the establishment of material and electronic component manufacturing specifications & related testing methods as well as equipment qualifications and process validations

173

Senior Quality Engineer Resume Examples & Samples

Responsible for leading SW quality engineering activities like: Designing SW Quality plans, overseeing the execution of SW Quality Plans, assessing complex software designs and reviewing test and other complex performance data, analyses market feedback, lead complex root cause analysis and complex SW Quality problem solving.  May also provide other SW Quality engineering support, including assisting organizational units in leading resolution of SW Quality engineering deficiencies
Use post-market analytics and statistics to report on software performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiate field actions when required
Act as a single point of contact (person assigned to project team) responsible to ensure that software design quality related requirements/criteria are completed and meet SW Quality standards for every PRP milestone
A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways
This job is the fully qualified, career-oriented, journey-level position. Has a complete knowledge of company products and services
Frequently interacts with subordinate supervisors, customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers and the company. Often must lead a cooperative effort among members of a project team
Bachelor’s engineering degree with > 5 years of related experience, or a Master’s degree with > 3 years of related experience
ASQ certification as Certified SW Quality Engineer or DfSS Green Belt / Black Belt
Working knowledge of appropriate global regulations, requirements, and standards
Experience with Agile Methodology

174

Senior Quality Engineer Resume Examples & Samples

Lead review of production batch records for completeness, adherence to open deviations, and compliance to regulatory requirements
Lead Material Review Board. Drive review of non-conformance events, the root cause analysis, and assessments to determine impact to product quality. Coordinate laboratory root cause investigations to resolve product fitness
Track progress of CAPAs and Quality Plans, and offer guidance and training to other Operations staff members responsible for their completion
Maintain training certification database, updating as necessary when new training documents are approved. Coordinate implementation of new competency trainings for scientific staff. Confirm completion of required on-the-job and classroom trainings
Work with each manufacturing team in efforts to update, standardize, simplify, and reduce the number of SOPs, as well as discontinue outdated SOPs
Material specifications: Represent manufacturing in efforts to identify and align critical quality specifications for incoming materials
Provide support to Quality Assurance team during internal and external audits to ensure FDA and ISO compliance

175

Senior Quality Engineer Resume Examples & Samples

Current software Development Experience with C# .Net Framework (4.0 or higher)
Experience implementing common software design patterns
Experience automating REST API’s
Familiarity with Test-Driven Development and Agile processes
Able to self-direct
Willing and able to mentor others in a team environment
Experience working with Specflow, Cucumber and other BDD tools
Experience mentoring, training, guiding other test engineers
Experience working on large scale distributed systems

176

Senior Quality Engineer Resume Examples & Samples

Responsible for analyzing all returned field failed materials, performing the required testing to resolve problems and preparing the necessary documentation and reports
Responsible for processing all service claims involving failed parts from the field
Utilizes failure analysis techniques to determine cause of failure and relays information to Engineering, Manufacturing and Service Engineering
Develops and maintains the Decatur warranty claim paperwork system and makes updates as appropriate. This claim system requires maintaining a complete paperwork system for the purpose of handling all formal responses as well as an informal system for hand-carried parts or direct shipped parts from dealer or engineering that requires paper documentation
Maintains, calibrates and develops new set-ups and uses for test equipment in the laboratory including the stress analyzer machine which is a prototype for the purpose of stress testing materials
College degree in engineering or equivalent experience in areas of product design and manufacturing with a extensive background in engineering design, principles and mechanics

177

Senior Quality Engineer Resume Examples & Samples

Support daily production activities and review change orders for adequacy
Maintain current knowledge of federal, state, and international regulations regarding GMP, ISO, MDD, and quality assurance
Ensure all documentation, reports, tests and results meet the requirements of Regulatory Filings and Technical files for CE filings
Work with manufacturing engineering to plan, execute, and document process validations
Identify and communicate product safety requirements to design team
Participate in supplier assessment, corrective action, and audits
Act as the quality representative for inspection and Material Review Board (MRB) activities
Participate in Design Control activities including specification development, V&V, Design Transfer, compliance to GMP requirements, design and program reviews etc
Participate in the project risk management activities including establishing risk documents such as risk management plans/reports and risk analysis
Contribute to formalizing and instituting the quality system, writing procedures, and utilizing quality tools and techniques to ensure product compliance to CE marking and QSR requirements
Experience with generating technical files is preferred
Plan, schedule, and complete projects in an aggressive, sense of urgency manner consistent with corporate objectives
Manage sterilization procedures and maintenance activities and the environmental monitoring program
Participate in the SOP writing and ensure that all Solta Medical employees follow written SOPs and process specifications
Participate in product complaint and corrective action system. Perform and support complaint and CAPA activities
Lead in supplier quality audits
Lead internal audits
Participate in Regulatory Assurance activities as required
Participate in audits including internal, USFDA and Notified Body
This position requires a minimum of an undergraduate degree in Engineering (preferably in Electrical or Mechanical engineering) or equivalent experience
Minimum 5 years in a medical device industry
Extensive knowledge and experience in medical device development and manufacturing, from concept to release and distribution
Extensive knowledge of the requirements for international quality systems, including ISO 13485, MDD, Vigilance Systems, Notified Bodies, CE marking and IEC 60601
Strong collaboration and development skills
Proactive, team player, enthusiastic, with high work ethics
PC experience with Microsoft Office applications (Outlook, Word, Excel, Visio, Microsoft Project, Power Point)
High level of attention to details, capable of efficient use of time and project management skills essential

178

Senior Quality Engineer Resume Examples & Samples

Primary contact to Technology and Advanced Manufacturing Engineering for support in new products, change management and problem prevention/resolution
Facilitate FMEA process with Design teams
Schedule and organize testing for new products and changes to existing products. Assure that all customer requirements are incorporated into the evaluation process
Preparation of technical reports for internal and external customers
Take initiative developing and forming teams to address critical product issues – with regards to both existing products and new product development
Drive continuous improvement and internal corrective action activities to improve the cost, delivery, and quality of products and services offered
Prepare technical reports relating to product changes and/or improvements, and drive resolution of issues related to these
Actively seek out and utilize technical expertise from within the company and from outside sources to assist in problem solving

179

Senior Quality Engineer, Mcio CIP Resume Examples & Samples

Drive cross-MCIO continuous improvement activities (i.e. Kaizen Events, Six Sigma Projects) including mapping current and improved states, driving corrective actions, and developing, tracking and measuring qualitative and quantitative results
Identify areas of opportunity (requiring corrective action) across MCIO
Mentor team members
Suggest MCIO Continuous Improvement Program modifications, as appropriate, to ensure strategic alignment, relevance and impact
Collaborate with continuous improvement and business excellence professionals across organizations to support and leverage Microsoft-wide, large-scale projects and programs
Highly developed oral and written communication skills with the ability to deliver controversial messages to senior management
Demonstrated ability to lead through a position of influence
7+ years of related experience
Undergraduate degree in business or related field; advanced degree preferred
Continuous Improvement certification (e.g. Six Sigma Green/Black Belt, Kaizen Professional) or equivalent experience preferred
Experience with operations highly beneficial

180

Senior Quality Engineer Resume Examples & Samples

Daily production support activities
Failure investigation
Development and implementation of corrective actions
Optimization of manufacturing processes
Process Validation
Quality control planning and test method development and validation
Optimization of quality systems and manufacturing procedures for THV operations
Initiation and approval of Device Master Record changes
Interfacing with the Draper, UT THV team regarding production transfer activities
Minimum of four years experience is required for the Senior Engineer level
Prior quality engineering experience in the medical device or pharmaceutical industry is required
A bachelor of science degree in mechanical or biomedical engineering (or equivalent engineering discipline) is required
Experience in the use of statistical tools required (SPC, Six Sigma, DMAIC, etc.)
Excellent verbal and written communication skills, teamwork skills, attention to detail and results orientation required

181

Senior Quality Engineer Resume Examples & Samples

Responsible for leading SW quality engineering activities like: Designing SW Quality plans, overseeing the execution of SW Quality Plans, assessing complex software designs and reviewing test and other complex performance data, analyses market feedback, lead complex root cause analysis and complex SW Quality problem solving
Ensures that appropriate SW Quality plans are made that include all stages of the software life cycle
Acts as a single point of contact (person assigned to project team) responsible to ensure that software design quality related requirements/criteria are completed and meet SW Quality standards
Independently audits the adequacy of design specifications, V&V test plans, and reliability test plans for software validation
Ensures product related data is collected and analyzed from performance in the field and evaluates it against reliability specifications for software
Uses post-market analytics and statistics to report on software performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates and reports field actions when required
Represents the Supplier Quality function within the Q&R department
Implements, maintains, and enforces a compliant and effective QMS
Responsible for ensuring compliance to worldwide QMS/product requirements as required, and ensuring policies/procedures for all products and operations are consistent with those requirements
Manages (local) Q&R processes and ensures (local) process ownership for all activities in scope
Actively educates and promotes the QMS to achieve a quality and regulatory compliance culture throughout the organization
Working knowledge of appropriate global medical device or consumer product regulations, requirements, and standards
6+ years of related experience in a medical device or regulated industry
ASQ certification as Certified SW Quality Engineer or DfSS Green Belt / Black Belt preferred
Experience managing a Quality Management System preferred

182

Senior Quality Engineer Capa Processes Resume Examples & Samples

A minimum of a Bachelors Degree is required
A Bachelors Degree in Engineering, a Life Science or a related technical discipline is preferred
A minimum of 4 years in a GMP and/or ISO regulated environment is required
Experience working in a Medical Device manufacturing environment is preferred
Strong knowledge of quality and compliance for Medical Device Industry (GMPs) is preferred
Working knowledge of complaints and regulatory issues are preferred
Working knowledge of FDA Quality System Regulations is required. Experience with ISO 9001/ISO 13485 standards is preferred
Working knowledge of Japanese Regulatory Requirements (JPAL) and other related medical device national regulatory standards is preferred
Demonstrated knowledge of business impact of compliance issues and risk management is required
Proven ability to build partnerships both internally and externally is required
Prior Project Management skills are preferred
Experience or training and/or certification in Process Excellence/Six Sigma are preferred. Strong communication, organizational, negotiation and interpersonal skills are required
The ability to collaborate with all levels of management across multiple sites and functions is required
A good working knowledge of related functions such as Operations, Supplier Management, Product Development and Procurement is preferred
This position will be based in Monument, CO and require up to 15% travel, including possible international travel

183

Senior Quality Engineer Resume Examples & Samples

Ensure design changes to existing products are conducted in compliance with the FDA Quality System Regulations Design phases
Participate on cross-functional teams to review marketing requirements and to develop concise, unambiguous, con-conflicting and feasible product requirements that support the market needs
Participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, DFMEA, and risk management report). Create a risk management plan, perform product risk assessment, facilitate the failure mode effects analysis, and create a final risk management report
Assist in the creation of verification and validation test plans. Oversee testing and analysis for standards and product requirements compliance
Provide guidance and direction for sample size and statistical analysis of verification and validation test results. Experience Statistics stools experience an advantage e.g. Minitab
Provide training to project teams on procedures, verification, validation, statistical methods and design controls
Review Design History Files and Technical Files for conformance to applicable requirements
DFSS / Lean Green Belt or Black Belt Able to analyze and chart data using MS Excel or Minitab
Familiar with IEC 60601 and product specific industry standards

184

Senior Quality Engineer / Supervisor Resume Examples & Samples

Drive the Scrap and Warranty Reduction Processes including the Rework and Material Review Board processes for Switchboard Assembly / plant
Establish and Improve data collection and analyzation processes and associated processes
Analyze data to identify key detractors of Scrap, Rework & Warranty and then implement Error Proofing solutions to achieve CONC goals
Support deployment of Eaton Quality System (EQS)/ISO9001, Eaton Lean System (ELS), & MESH
Serve as an Internal Systems Auditor performing process & systems audits on a regular basis, including process audits and EQS / ISO Assessments
Supervise Quality Assistants and Technicians as required by providing coaching and development as required to ensure continuous improvement objectives are achieved resulting in improved process and product quality
Lead 8D Root Cause Action / corrective action activities. Uses data analysis software (i.e. Excel, Access & Minitab)
Lead the Panelboard Quality Council
Leads improvement teams, in the development and evaluation of process capability, process control plans, analysis of out-of-control conditions and process audits
Participates in, and may lead the auditing of internal Quality Systems and completes part approval documentation to assure that customer requirements are met in new or modified products and processes
Participates in product development and launch activities including identification of customer expectations, manufacturing and test support, reliability analysis, design reviews, evaluation of test programs, material testing
Bachelor’s Degree in Engineering or Technology from an accredited institution
Minimum 1 year of Quality Experience in a Manufacturing Environment
Must be legally authorized to work in the United States without company sponsorship
Minimum 5 years of Quality Experience in a Manufacturing Environment
Six Sigma Greenbelt Certification
Demonstrated proficiency in interpersonal, analytical and organizational skills
Demonstrated ability to lead cross-functional collaboration
Strong written, verbal and computer business communication skills required
Demonstrated proficiency in Microsoft Office software (i.e. Excel, PowerPoint, Word, Outlook, Visio, Project, Minitab)
Understanding of Eaton Business System
Understanding of Eaton Quality Systems and ISO Standards
Understanding of Eaton Safety Processes (MESH)
Understanding of PROLaunch Process
Understands basic electricity principles
Understanding of Panelboard operation/functionality
Understanding of Switchboard operation/functionality
Thorough understanding of problem solving methods-i.e. Six Sigma, 8D, root cause analysis, and the associated
Statistical tools used to analyze problems, evaluate and complete improvement projects
Knowledge and understanding of Eaton’s corporate Supplier Quality Assurance requirements

185

Senior Quality Engineer, Greenville Resume Examples & Samples

Write, review and approve Exceptions, CAPAs, Customer Complaints and Change Controls in the Electronic Quality Management System (EQMS)
Review and approve OOS investigations in the Quality Stream module
Generate data for Annual Product Reviews
Lead Material Review Boards
Interact with functions to ensure that internal audits are conducted on a continuing basis as specified to enforce requirements and meet specifications
Lead and participate in Root Cause Analysis teams
Lead and participate in Process Improvement Teams
Respond to customer inquiries and generate written correspondence and reports based on internal or customer requests
Review quality systems documentation through consistent review of document revisions to GMP controlled documents and support Drug Master Filings
Maintain and manage the Returned Goods program for the site
Serve as a back up host for customer audits
Perform GMP walk-throughs with production on a routine basis
Maintain compliance wire training
Minimum of 5 - 8 years of experience in Quality Control/ Quality Assurance in a pharmaceutical manufacturing environment
3+ years of experience managing investigations, OOS, CAPA's and change controls
Demonstrated expertise in root cause analysis tools
Understanding of basic statistical principles and regulatory expectations
Proficient in Metric Stream, BPCS and Trackwise applications
Knowledge of GMP's for APIs
Ability to quickly identify, communicate and/or resolve issues
Ability to effectively communicate to customers, internal and external

186

Complaints Senior Quality Engineer Resume Examples & Samples

Bachelor's Degree in an engineering discipline or related technical field
6+ years within a supplier quality organization
Expertise in implementing and maintaining quality systems
Experience in problem-solving and root cause analysis
4+ years in the Medical Device or Pharmaceutical industry
Proven track record of successfully working with cross functional teams in a fast-paced and dynamic environment
Familiar with 21 CFR Part 210, 211, 820, ISO 13485, ISO 14971
Extensive experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes) and ability to mentor stakeholders in analysis of process data and metrics to identify root cause of complex problems and development and implementation of preventative or corrective actions
Experience in electronic quality system modules such as ComplianceWire, CATSWeb, Documentum, QlickView etc
Expertise in providing creative solutions to complex issues

187

Senior Quality Engineer Resume Examples & Samples

Primary QA point of contact for on-market medical device and diagnostic complaint assessments and post market surveillance
Work closely with investigation teams to identify, assess and track potential adverse events and/or field actions and escalate to Regulatory in a timely manner
Monitor new and revised regulatory requirements in the area of Regulatory Compliance and translate information into area processes
Participate as the subject matter expert during audits and/or inspections as needed
Actively participate on Quality teams and cross-functional project teams as needed
Facilitate the evaluation of complaints, including assessment, investigation, containment, review, approval and determination of on-going needs
Ensure adequacy of complaint records (e.g. investigations, CAPA, NCs)
Identifies, collects, trends, analyzes, and summarizes product quality data to identify product quality issues
Promotes global awareness and provides training to policy and procedures
Provides support in the execution of field actions
Contributes to the establishment and maintenance of product risk management
Provides management with status updates on assigned responsibilities and goals and escalates issues in a timely fashion
5+ years recent experience in Quality/Regulatory Affairs in a in vitro diagnostics device or medical device required
Strong knowledge of U.S. FDA regulations of medical device/IVD adverse event and field action assessment, health hazard evaluation, product risk safety analyses, MDR/recall reporting, IVD/Medical Device labeling requirements and 21 CFR 820 and process requirements. Strong knowledge of Vigilance reporting to OUS regulatory agencies desired

188

Senior Quality Engineer Resume Examples & Samples

Completes Quality Engineering assignments with minimal supervision
Coach, mentor, and train quality engineering team members
Formulate and implement quality assurance procedures, policies, and standards
Subject matter expert on Eaton Quality System, AS9100, NADCAP, and customer specific requirements
Monitors/manages new program metrics and facilitates efforts to drive continual improvement within plant value streams or new program launches
Execute on customer, operations, or new program technical deliverables
Support on-time delivery of orders through the manufacturing process including DMR resolution, process, verification activity, and FAIR/Source/Conformity activity
Lead and provide technical advice and counsel to cross-functional teams
Host or participate in customer and third party audits as needed along with providing technical support
Work directly with production associates on the implementation of new products/projects in order to build an inclusive culture that meets the needs of all employees and customers
Utilization of problem solving skills and toolkit: 5 Why, 8D, A3, Fishbone, etc
Benchmark other sites for best practices and process improvements opportunities
Ensure quality documents align with the recognized Aerospace Quality System Standards as well as Eaton Objectives, policies and procedures
Bachelor degree in engineering or related technical field
Minimum 2 years of engineering or manufacturing experience
No relocation benefit is being offered for this position. Only candidates that currently reside within the immediate geographical area of 50 of Jackson, MI will be considered
Bachelor degree in mechanical, industrial, or aerospace engineering
Experience with project management a plus
The ideal candidate would have 2-5 years of experience in a quality engineering role
Knowledge of machining, assembly operations, gauging, SPC, APQP, and quality assurance systems (ISO 9001, AS9100)
Strong project and time management, organizational, and analytical skills
Ability to communicate effectively with all levels of the organization, from production associates to the leadership team
ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Manager of Quality/Organizational Excellence (MOQ/OE) is preferred
Knowledge of standard manufacturing process, metal forming, assembly/test in an Aerospace environment preferred

189

Senior Quality Engineer Resume Examples & Samples

Understand the application under test, participate in all levels of testing activities, and work closely with all functions of the Scrum team as well as with surrounding teams DevOps, Test Engineering, Test Architecture and Environments
Maintain and extend HMH’s custom UI and API Automation Framework (using Protractor, Selenium Webdriver, SOAP UI and other testing tools as required), which is a collection of commonly used automated testing tools, by adding features, implementing enhancements and fixing issues. The QE may also be involved with back end testing
Automate the creation of test data to ensure a consistent test environment
Build test harnesses to test software components at the most efficient level
Influence and coach "design for testability" early in the development cycle by working as part of our product design team
Partner with developers in Agile sprints to develop test plans that form part of each story
Define and execute a product quality strategy and actively participant in deployment with all levels of verification
Involvement in maintaining and executing UI and API test plans in Continuous Integration platform (like Jenkins or Bamboo), drive the effort of implementing efficient Continuous Integration / Continuous Delivery environment, and actively participate with setting and maintaining standards of good practices for functional and automated testing for frequent and effective execution. QE will adhere to automation ‘best-practices’ and standards to allow for easier collaboration among automation team members to increase the quality of the automation code
Actively participate in the Scrum team Agile ceremonies like: sprint planning, daily stand-up, sprint retrospective, sprint review, backlog grooming, review delivery readiness, etc
Participate in training and mentoring other team members to help develop better automation outcomes
5+ years of experience and a bachelor’s degree in computer science or related field
Familiar with Testing Frameworks, Test Design Patterns, Release, Defects and Test Management tools, source control tools
Familiar with Testing Frameworks like: JUnit, TestNG, Test Design Patterns like: Page Object Model, Page Factory, Robot Framework

190

Senior Quality Engineer Resume Examples & Samples

Lead / Guide Junior Quality Engineers to develop and implement Quality test strategy, test plan
Responsible to System / Integration test REST API’s, User interface, Database, reporting, ETL / Batch technology components
Perform complex testing with EDI X12 (274, 278, 834, 837 etc) / JSON/XML API transactions
Explore new tools and capabilities to automate System integration testing so it supports continuous delivery / DevOps software development methodology
Come up with innovative ideas / suggestions to resolve complex integration issues / defects
Present System - integration test results to the project teams and Business / IT leaders
4+ years of Quality Assurance testing experience in a web application environment testing User Interface, Database, Web services, API’s, Batch / ETL components
1+ years of hands - on testing experience working with complex XML / JSON, MQ interface, EDI X12, SQL transactions
3+ years of hands - on scripting / coding experience in any one of the below Java automation testing tools such as Spock, Groovy, Selenium, Gatling, JUnit, Geb, Cucumber, C++, .Net or other similar tools which uses object oriented programs
A demonstrated ability to analyze and write JAVA code

191

Senior Quality Engineer Resume Examples & Samples

3 to 5 years of experience within a manufacturing setting
Bilingual English/ Spanish
Additional education/training in Quality Assurance, management, statistics, and program management is desired

192

Senior Quality Engineer Resume Examples & Samples

Identify test suite gaps and develop test strategies
Define Acceptance criteria
Develop test frameworks and tools for test automation and execution
Collaborate with SW developers and support teams
Ability to work both on your own and as part of a team
Excellent communication skills working with geographically distributed departments and teams
Ability to quickly learn new technologies and adapt to a growing and evolving team environment
Ability to thrive in a fast-paced and rapidly changing environment

193

Senior Quality Engineer Resume Examples & Samples

Partner with cross-functional leadership to ensure all aspects of Product Development are performed in conformance to the quality management system and regulatory requirements
Accountable for Quality of Ultrasound products, and execution of continuous improvement for projects, supplier Quality initiatives and process improvement/development project(s)
Engage and understand the industry environment for Ultrasound best practices and be able to execute and implement those requirements as the business dictates. Specifically these areas include Engineering (process, material and product design), Quality (Six Sigma, DOE, Validation, etc.) and Documentation (Operating procedures, Contracts, Agreements, Training, etc.)
Review product lifecycle documentation against product and process requirements using specifications, materials, tools, techniques, and methodologies in accordance with applicable procedures and standards
Identify, report and follow-up on process adherence issues
Improve customer satisfaction through Quality initiatives and continuous process improvements
Ensure process harmonization in a global environment
Update existing processes, and develop new ones as required
Train the organization on new and updated processes
Execute mock-audits, report findings and follow up on issues

194

Senior Quality Engineer Resume Examples & Samples

Creation and execution of manual and automated test cases for functional, regression and end-to-end testing, including API, database and front-end testing of the entire system, subsystems and interfaces to other systems
Participate in functional and technical requirements discussions with Product Managers, Product Owners, Architects and User Experience teams
Be a subject matter expert for teams in terms of quality assurance and test related processes, methods and tools

195

Senior Quality Engineer Resume Examples & Samples

Professional knowledge of quality tools （SPC, MSA, APQP, PPAP, etc.）
Problem Solving Skill （8D, 5 Why etc.）
Experience in quality and process control of injection molding, stamping/forming or surface treatment respectively would be an advantage
8 years working experiences in quality section at least
Familiar with office software
Fluent English and Good communication skill
Coordinate production according to quality of vendor, as well as, train quality control staffs in order to execute quality policy of TESZ. Control vendor quality within TESZ QC system
Evaluate supplier quality performance and audit the supplier
Check quality status of product provided by both internal and external suppliers, take preventive action actively to guarantee the finished goods quality
Feedback the defective part’s information that were detected in Incoming Inspection to supplier on time, require supplier to take corrective action and check countermeasure complete status
Work with supplier together to find out the root cause, complete correction action report and check countermeasure complete status
When get some complains from customer, will work with related component’s supplier to find out the root cause, conduct the correction action and check countermeasure complete status

196

Senior Quality Engineer Resume Examples & Samples

Provide general Quality Assurance support, guidance, review, and approvals to areas of manufacturing operations, supply chain, product development, or field/product quality
Build a supplier relationship to move the company forward as a clinical organisation
Review and reporting on supplier performance metrics
Ensure processes are carried out in accordance with policies, procedures, and requirements
Assignments may include areas such as supplier quality, non-conformance, deviations, product release, control of documents, complaint handling, investigations, CAPA, material control, audits, etc
Identify, resolve and, where needed, escalate deviations or potential product quality risks working directly with other functions to resolution
Work directly with internal customers or other functions to resolve simple to moderately complex deviations and issues
Generate and analyse metrics charts and graphs. Recommend actions; develop and lead action plans, reporting to local management
Be recognised as an independent, first line resource for assessing and resolving issues
EU and Global travel to supplier/vendor sites (up to 25%)
Bachelor degree in an engineering, science or quality; advanced degree desirable; quality certification desirable
Experience in facilitating client regulatory audits including ISO 13485 desirable
Experience of carrying out quality audits of suppliers to the ISO 13485 standard is required
QMS Implementation experience
Proven experience in Quality Assurance within the medical or Pharma industry
Excellent written, verbal and organisational skills required
Professional Membership Quality Institute or similar is highly advantageous
Positive, detail oriented and able to work independently
Operates well in a fast pace and changing environment
Open minded, collaborative and able to work in a non-hierarchical environment
Ability to look at processes high level as well as zoom in on a detailed level
Strong interpersonal skills and ability to articulate a motivating quality vision to others
Pragmatic in defining a quality path that achieves key goals while recognising resource constraints
Highly independent – capable of delivering without the need for day to day input
Project management skills required

197

Senior Quality Engineer Resume Examples & Samples

Bachelor’s degree in engineering required
4 or more years experience with a Bachelors degree in engineering or two or more years with a Masters degree in engineering
3 or more years Quality Engineering
Certified Quality Engineer, Six Sigma Blackbelt, Quality Auditor, Reliability Engineer, or equivalent desired
Experience in medical device design and application of test standards
Minimum of five years industry experience, preferably in the medical device manufacturing industry
Working knowledge of IEC606-1, UL2601-1, EMC Directive, and other appropriate industry standards Complete understanding and wide application of technical principles, theories, and concepts in the field
Ability to provide technical solutions to a wide range of difficult problems. Solutions are imaginative, thorough, and practicable, and consistent with organizational objectives
Cross-functionally and an effective team player
Experience in application statistical methods to design reliability and process capability
Must be able to work in a team environment and exert influence without alienating others
Working knowledge of statistical analysis/software experience preferred
Proficiency in Microsoft Project

198

Senior Quality Engineer Resume Examples & Samples

Bachelor’s Degree in Engineering or related discipline required
Preferred (5-7) years Quality experience in manufacturing environment
Experience performing validations (IQ, OQ, PQ, MSA, CQ)
Experience in FDA regulated industry, helpful
Effective analytical, technical, and problem solving skills
Effective verbal presentation skills to small and/or medium sized groups
Demonstrated ability to manage projects and multiple priorities
Demonstrated knowledge and ability to use common software tools for spreadsheet, word processing, and presentation tasks

199

Senior Quality Engineer / Supervisor Resume Examples & Samples

4+ years related Quality Engineering experience
Engineering statistical tools
Problem solving and process improvements techniques
Experience establishing Receiving Inspection procedures and sampling plans
Experience working within a regulated environment preferably in Medical Devices or Pharma
Excellent Verbal and Written Communications
Experience managing incoming inspection teams
LEAN/Sigma methodology experience
MBA or MS, preferably in science or engineering
Strong background in the quality requirements in the manufacture of implantable medical devices

200

Senior Quality Engineer Resume Examples & Samples

4 + years of experience with a Bachelor’s degree
2+ years of experience with a Master’s degree
4+ years of experience in the Medical Device industry in design and development of Medical Devices

201

Senior Quality Engineer Resume Examples & Samples

Support quality improvement initiatives that lead to continuous / cost improvement
Analyze effectiveness of preventive and corrective action and review root cause investigations
Partner at cross functional level to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges. Supports new product introduction as part of design transfer
Ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality
Ensure effective quality strategies are created for the validation of test methods, process and design
Create, modify and approve Inspection Sheets used in production
4-6 years related experience
Fluency in English and German required
Ability to perform "hands on" troubleshooting and problem solving
A thorough understanding of GMP/ISO regulations (ISO 13485; ISO 14971…) and validation regulations is preferred

202

Senior Quality Engineer Resume Examples & Samples

Bachelor’s Degree in an Engineering or Scientific discipline
An advanced degree in a related field is an asset
Minimum of 4 years of related experience in a regulated industry
Medical device industry experience is preferred
Experience with FDA CFR 820 and ISO13485 requirements is preferred
Experience in New Product Development in a regulated industry is preferred
Experience in conducting verifications and validations is an asset
Experience in conducting risk management activities (i.e. P/DFMEA) is an asset
Familiarity with inspection methods and techniques is an asset
Familiarity with statistical analysis techniques and tools is an asset
Excellent problem solving and decision making skills will be required
Interpersonal skills that foster conflict resolution as it relates to technical situations will be required
Process Excellence / Design Excellence / Lean experience is preferred

203

Senior Quality Engineer Resume Examples & Samples

Lead cross-functional teams to drive process and product improvements
Lead problem-solving teams; use of QA methodologies to manage and facilitate issue resolution including root cause investigations and the development, implementation and monitoring of effective corrective and preventive actions
Work with Manufacturing and Design Engineering to determine product specifications and tolerances
Audit manufacturing line against released manufacturing processes and procedures
Strong interpersonal and communication skills are an absolute requirement to establish effective working relationships throughout the Tesla organization
A Bachelor of Science degree in engineering or other technical discipline
5-10 Years of experience in JIT Seat Manufacturing facility
Familiarity with compliances and Legal requirement of automotive seating regulation
Experience with various reliability test techniques including HALT and HASS testing
Experience with broad variety of measurement and inspection techniques

204

Senior Quality Engineer Resume Examples & Samples

Set-up & Maintain project Quality plan, drive project team to achieve goal
Perform quality assessments during development stage, provide comments for all project maturity gate reviews
Ensure that Key, Identified Program deliverables are completed on time per the project schedule and meet excellent quality standards
Set up lesson learn database and Drive wide for new program lessons learned from starting, FBA
Customer PPAP/ISIR preparation and submission for approval, and achieve the customer approval in time with related team
Participating the customer quality meeting to define problem identification, resolution and to convince them with countermeasure provided by Harman plant Quality team
Lead Harman plant quality team to achieve the customer approval on Harman plant audit by the customer
Responsible for customer plant containment and rework activities, such as product software re-flashing
Support manufacturing quality onsite at HARMAN manufacturing locations as needed
Fluent English Language
Minimum 8+ years of previous experience in quality, electronics or manufacturing engineering
Experience with problem solving methodologies, customer service and automotive quality management systems

205

Senior Quality Engineer Resume Examples & Samples

Provides Quality Engineering support in Supplier Quality using (WISPER) Worldwide Interactive Supplier Performance Evaluation Reporting to interface with Suppliers to support measurement of their performance
Gathers factual data and leads 8D teams through Measure Analyze Improve and Control (MAIC) process to reduce scrap, rework and other waste
Performs internal and external audits to the ISO9001 and EQS standard
Provides tactical supervision to quality technicians and lab technicians, as well as execution of a cross-training plan for Quality department, continued development of the team’s skills and competencies. Supports EHS requirements for zero-incident culture for the work environment
Assists with driving an engaged work-force culture within Empowered Work Teams to create an understanding in the application of the Quality tools; drives execution of A3 problem-solving in Empowered Work Teams
Provides support and aid in the progression of ISO9001 and Eaton Quality System (EQS) compliance
Assists in developing, maintaining and keeping current Process Failure Modes and Effects Analysis (PFMEA’s), control plans, and related activities per Eaton policies and AIAG guidelines
Assists customers with quality related issues
Provides manufacturing engineering support through capital planning management and execution
Drives long term vision of assigned roadmap to support reduction of DPPM
Coordinates with customers to ensure packaging specifications align with customer expectations
2 years of experience in a quality function
Must live within 50 miles of Mountain Home, AR
Experience working with supplier quality
Six Sigma Black-belt, Green-belt, and/or CQE certification by ASQ
Knowledge of Advanced Product Quality Planning (APQP) process
Decision-making in relation to manufacturing with no supervision
On call 24/7 for any manufacturing issues
Thinking and acting strategically
Problem solving and leadership skills
Building organization capability with a drive for results

206

Senior Quality Engineer Resume Examples & Samples

Experience with composites, chemicals, calibration, and lab testing
Experience with auditing and source inspections
Familiarity with SPC (Statistical Process Control)
Experience in either commercial, military, or business aviation/aerospace
Exposure to Epic or equivalent system, such as Windchill PDM, Enovia PLM, etc
Experience with CATIA / Solid Works, Solumina, and various metrology applications

207

Senior Quality Engineer Resume Examples & Samples

Continuously improve deep understanding of Java and microservices architecture
Prepare strategies for migrating to microservices architecture
Actively participate in defining testing strategies for Obsidian
Design and develop applications and scenarios used for testing
Create test automation frameworks for various environments
Analyze and prioritize the quality risks posed by JBoss solutions and determine the tests required to mitigate these risks
Provide root cause analysis for complex bugs reported by our customers, communicate the impact of these bugs to customers, developers and support specialists
Solid experience with Java EE development
Experience with migration is an advantage
Understanding of the fundamental design principles behind a scalable application
Experience with debugging and performance tuning is a plus
Experience with high availability and load balancing is an advantage
Docker and Platform-as-a-Service (PaaS) experience
Experience as a people manager is a plus
Familiarity with Red Hat Enterprise Linux (RHEL) or UNIX-like operating systems
Ant, Maven, Gradle, SVN, and Git experience
Continuous integration experience
Passion for open source

208

Senior Quality Engineer Resume Examples & Samples

Continuously improve deep understanding of Enterprise Java platform technologies
Active participation in defining testing strategies for JBoss Enterprise Application Platform
Design and develop enterprise applications and scenarios used for testing
Create test automation frameworks for environments like clouds, multiple operating systems, large clusters, containers, etc
Analyze and prioritize the quality risks posed by JBoss products and determine the tests required to mitigate these risks
Provide root cause analysis for complex bugs reported by our customers; communicate the impact of these bugs to customers, developers, and support specialists
Experiences with Java EE development
Debugging and performance tuning experience is an advantage
Familiarity with high availability or load balancing is a plus
Knowledge of Docker and Platform-as-a-Service (PaaS)
Experience as team leader is a plus
Background in Red Hat Enterprise Linux (RHEL) or UNIX-like operating systems
Understanding of Ant, Maven, Gradle, SVN, and Git

209

Senior Quality Engineer Resume Examples & Samples

Create and maintain new test infrastructure and tooling
Perform testing and automation
Program in Java, Go, and Python
Contribute to virtualization and advanced storage
Work with various architectures and hardware configurations
Debug issues in relevant areas
Professional software quality engineering experience on Linux or UNIX platforms; Linux or UNIX system knowledge at a system administrator level is a plus
Expertise in building and maintaining test environments and automated data-driven test suites
Advanced coding abilities using Java EE, Go, and Python
Experience with Red Hat Virtualization, Foreman, containers, and JUnit is a plus
Cassandra databases, OpenShift, Docker containers knowledge is a plus

210

Senior Quality Engineer Resume Examples & Samples

Position requires a Bachelor’s of Science Degree in Engineering or equivalent experience, and 7 to 10 years direct Quality Engineering experience
Experience in regulated medical device manufacture with compliance to FDA Quality System Regulation, EU Medical Device Directive and ISO 13485 is a plus
Plastic product manufacturing experience is a plus

211

Senior Quality Engineer Resume Examples & Samples

Interpersonal Relations
Fluency speaking and writing in English and Spanish
Technical Writing and Composition

212

Senior Quality Engineer Resume Examples & Samples

BA/BS degree in a technical discipline (i.e., engineering, computer science, quality assurance) with 5 years of experience
Must be able to attain a Secret clearance classification
Must be a United States Citizen
Must be able to attain NASA certifications in harness, Printed circuit board and polymerics inspections
Complete understanding of quality system
Proficient in the use of most tools, measuring and test equipment
Ability to participate in proposal development and reviews
Understanding and use of TQ tools in daily work
Ability to lead process development and implementation tools
Technical writing skills for procedures and processes and drafts policies for review
Ability to interact with external and internal customers and senior management personnel
May possess a Certified Quality Engineer (CQE) certification

213

Senior Quality Engineer Resume Examples & Samples

Develops and implements product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analyses, FMEAs in conjunction with other product development team members. May be responsible for risk analyses and FMEAs
Collects and analyzes Leads Manufacturing process defect dataProduct/Process improvement efforts (e.g. scrap, nonconforming product, customer complaints) by systematically gathering quality metric data and performing the appropriate analysis method(s) to enhance sustaining product design and new product development
Creates Quality Tools & Training Materials by applying body of knowledge/expertise and communicating to respective teams

214

Senior Quality Engineer Resume Examples & Samples

Generally requires 4-6 years related experience
Knowledge of product/process Risk Management (FDA and ISO standards) is required
Experience with implementation of risk mitigation is preferred
The ability to perform "hands on" troubleshooting and problem solving is preferred. The ability to think on the feet and providing sound judgment is highly desired
Knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position
Demonstrated project management and project leadership abilities are preferred
This position may require up to 30% travel and will be based in an MD&D manufacturing facility

215

Senior Quality Engineer, Shanghai, HIS, SPS Resume Examples & Samples

Take responsibility on quality monitor/process control of sensor and instrument manufacturing, support/coach QC inspectors on QC procedures and inspection criteria
Create and implement inspection procedures, handle and coordinate quality issues raised in daily QC inspections
Verify issues reported from both production and customers, generate test/analysis reports as well as corrective/preventive actions and drive/assist to realize accordingly
Work closely with PV team on new products validation, set up inspection and test standards for new products based on requirements of customers and various mandatory standards
Lead to work out PFMEA and control plan as part of new product introduction
Regularly review and update PFMEA to standardize best practices and find potential risks, follow up actions and effectiveness for top risk failure modes
Well know about all quality metrics and identified top3 of COPQ,CPPM,FPY, drive cross functional team for analysis and problems solving to achieve the target
Establish practical and efficient quality improvement plan to ensure PQC and OQC team

216

Lead / Senior Quality Engineer Resume Examples & Samples

Ensures and coordinates the quality of products during development projects and product lifecycle
Is the leading senior quality engineer on a development project and represents quality/reliability in the project core team
Implements quality requirements into the business requirements document
Follows strategic quality rules and targets during product development
Estimate resource requirements for projects
Broad engineering skills and leadership capability
Intuitive, yet grounded in facts
Innovative , yet questioning of unproven technology
Visionary, thought leadership yet practical
A hard driving teacher, motivator, and disciplinarian, yet a patient listener
A no-compromise attitude achieving breakthrough targets
A good communicator
Always ready to get his or her hands dirty

217

Senior Quality Engineer Resume Examples & Samples

Assures that the site Quality Systems comply with all applicable sections of 21CFR, ISO standards and internal quality system procedures
Participates in elements of investigations regarding customer complaints. Provide failure analysis of product systems for identification of corrective and preventative action
Conduct internal Quality System audits to assure compliance with domestic regulations and international requirements
Perform Process Validation (IQ, OQ & PQ) for new product transition from Research and Development to manufacturing and production
Monitor qualification, verification and validation studies in support of product and process changes
Participate in MRB activity to assure timely resolution of material non-conformance and corrective action
Bachelor’s Degree in Biomedical Engineering preferred
Experience with post market surveillance, complaint processing, trending, and investigation preferred
Proficient in the use of Microsoft Office (Word, Excel, Access, PowerPoint)
Time Management. Must be a self-starter with the ability to follow general directions in accomplishing assigned work
Decision quality and presentation skills

218

Senior Quality Engineer Resume Examples & Samples

Has intermediate to expert knowledge of commonly-used concepts, practices, and procedures within the Quality Engineering field
Can establish guidelines to perform the functions of the job
Ability to communicate effectively both orally and in writing and to establish and maintain cooperative working relationships with persons contacted in the course of performing assigned duties
Ability to organize and prioritize workflow and to meet established timeframes
Ability to maintain updated knowledge of procedures, products and activities of assigned area
Manage and Lead teams doing quality inspections
Evaluate, update, and deploy new processes and process improvements
Requires a 4-year degree in an engineering discipline or equivalent training/experience
Requires 5-10 years work experience; QA experience a plus
Knowledge of Lean Manufacturing concepts a plus
Knowledge of Six Sigma concepts preferred
Medical product manufacturing experience preferred
Customer return handling experience in medical devices preferred
Ability to perform multiple tasks concurrently with accuracy
Lead or supervise quality inspectors
Demonstrated understanding of FDA Good Manufacturing Practices (GMP)

219

Advanced Senior Quality Engineer Resume Examples & Samples

Bachelor's Degree in Engineering plus 8 years of related experience is required
The successful candidate must be able to obtain NASA Workmanship certs
Experience as a multi-disciplined” engineer (Hardware and software assurance engineer)
The successful candidate will have failure review board experience. Not necessarily an inspector

220

Senior Quality Engineer Resume Examples & Samples

Responsible for all issues and CARE2 operation and field support and plant Liaison that is related to all of e-PT components (RESS, HPDM, OBCM, SPIM, ACCM, MOTOR, Battery Heater)
Manages the process and procedures to refurbish service parts and ensure good parts are being shipped to our customers
LI-JH1 LI-JH1

221

Senior Quality Engineer Resume Examples & Samples

Prepares an input for the proposal write-up
After receipt on contract, the Quality Engineer is responsible for generating the procedures required to assure that all contractual quality requirements are adhered to
Assists in the preparation, review and approval of specific quality documents in compliance with contractual requirements. These documents shall include, but not be limited to; Manufacturing Procedures, Drawings and Revisions, Procurement Specifications, Qualification Test Procedures, Acceptance Test Procedures, Program Quality Plans, Special Process Procedures, and Training Documents
Coordinates the development of a Receiving Inspection Plan (RIP)
Coordinates inspection requirements with customer and Government representatives
Evaluates inspection equipment and tooling requirements to meet contractual quality specifications
Develops, for each new program as required, with the cognizant project engineer, the plan by which the reliability of the system, subsystem, or component shall be demonstrated
Supports engineering design personnel in the initial design phases of programs undertaken by PCA. The prime consideration is the inclusion of a maximum inherent reliability factor in the diagram
Reviews Development Test Plan and monitors testing
Monitors and approves the qualification test and lot acceptance test programs at PCA and independent test labs
Participates in customer design reviews
Reviews requests to purchase and provides quality requirements
Maintains material configuration on assigned programs
Reviews assigned job travelers for correctness and applicability of procedure, material requisition, and nomenclature
Monitors inspection and functional test data, and isolates potential problem areas as indicated by significant lot-to-lot data shifts
Analyzes, complies, and makes available to management and engineering personnel, quality assurance and reliability data that can be used to predict the performance characteristics of system component. This function includes periodically updating reliability estimates
Reviews discrepant hardware and recommends disposition. Participates in failure analyses and Material Review Board actions
Participates in customer and in-house audits
Devises programs for preventive quality assurance
Maintains a close and effective relationship with customer and government quality assurance/reliability representatives, acting as liaison between these individuals and PCA
4+ years of experience in Quality Assurance and/or Reliability Engineering
Must have a general working knowledge of current quality specifications, such as: ISO 9000, ISO 9004 and/or AS9100
Must be cognizant of the moral, as well as technical, requirements of Quality Assurance

222

Senior Quality Engineer / Quality Manager Resume Examples & Samples

Ensure any manufacturing and supplier quality issues are dealt with effective with root cause diagnosis, and information leading to appropriate corrective / preventive action using 8D methodology
Participate and lead manufacturing continuous improvement [kaizen] initiatives
Implement and maintain key metrics, service levels and benchmarking initiatives to continuously improve Manufacturing and Supplier quality performance within the factory
Prepare and submit monthly Manufacturing Quality metrics and report
Effectively define, plan, implement and maintain quality control activities
Ensure relevant quality control processes and procedures are effectively deployed and maintained
Support the Production Manager in the day to day activities of quality control resources to ensure productivity and quality performance goals are achieved
Support the production manager in the development and coaching of the Quality Control resources
Maintain and ensure ongoing compliance of Manufacturing quality processes and procedures ISO 9001 and regulatory requirements
Investigate, analyse and report on Manufacturing 'special case' product and process failures
Develop GSC and LoB quality partnerships
Meet or exceed agreed and defined KPIs/project milestones
Conduct Supplier Audits and develop supplier relationships to help improve supplier quality where required
Define and implement action plans to improve manufacturing process robustness using PFMEA
Support departmental policies, procedural objectives and requirements
Work in conjunction with Cluster Global Quality Leads and Managers to ensure an integrated approach to providing ’best in class’ solutions
Interact with Quality professionals across the company to share best practice and capitalise on synergies
Perform Safety Tours
Engage, motivate and participate cross functionally with colleagues at all levels
Adapt quickly and smoothly to changing operational requirements
Participate/co-ordinate/manage Manufacturing quality improvement projects and initiatives
Communicate effectively at all levels of the business
Practical, pragmatic and with good analytical skills
A ‘hands-on’ approach is essential
Demonstrated experience in a Manufacturing environment
Relevant supervisory or management experience in Manufacturing and / or Operations or similar position, with an emphasis on either / or manufacturing / design / supply chain / service / quality
ISO 9001 awareness and practical application
Degree educated or HNC/D in Engineering, preferably Electronic, Electrical or Mechanical Engineering
Equivalent of ‘Lean’ Green Belt training desirable
Able to demonstrate good communication abilities
Quality experience in a regulated industry and engineering experience in a process based industry preferred
Knowledge of SAP 6.0 desirable

223

Senior Quality Engineer Resume Examples & Samples

Bachelor degree of Electrical engineering
Relevant years of experience required
Excellent commend of English
Professional user of Microsoft Office
Working with team
Adhering to the principals & values
Learning & Researching
Adapting and responding to change

224

Senior Quality Engineer Supervisor Resume Examples & Samples

Customer interface for Returned Sales providing Failure Analysis and Corrective Action
Supervise team members’ daily activities in Approvals and product Quality support
Coaching and mentoring of 6 quality technicians & engineers on technical, leadership, internal and external communication, & project management skills
Ensure quality team is integrated into cross functional activities, namely in the areas of leadership, sense of urgency and proactive behavior
Creating a learning environment, utilizing both classroom and on the job training to advance quality tools and Six Sigma acumen
Champion a “zero defects” approach, proactively improving product/processes to eliminate internal rejections and customer escapes
Work directly with Advanced Manufacturing Engineering (AME), manufacturing personnel and members of quality to accomplish strategic initiatives
Assist in advancing HOS (CI’s, BIQ, 5S, tier escalation, visual management, standard work)
Ongoing metrics support for Cost Of Product Quality / Scrap, PPM & Return Material Authorization Days Open, First Pass Yield, Corrective Action tracking
Experience with deploying Statistical Process Control
Customer communication on key issues, regarding issue resolution
Lead implementation of ISO9001:2015 & AS9100:2016 Quality Management System upgrades
Manage Internal Audit system, including audit schedule, analysis of results for presentation to site leadership (during Management Review), and escalation of tools/resources needed to address compliance gaps
Bachelor Degree in Engineering or technical field, preferred Electrical or Mechanical Engineering,
Minimum of 3 years of technical team leadership experience in a manufacturing environment
US citizenship, based on ITAR requirements for products & customer documentation
Experience in AS9100 aerospace or ISO9001 industrial Quality Management System
A current ASQ CQE certification is highly desirable
Current Six Sigma Green Belt / Lean Certification or ability to achieve within 18 months
Experience with six sigma (DMAIC) problem solving skills including variation reduction, application SPC, PFMEA’s, associated control plans and mistake proofing
Proficient in project management skills with ability to manage multiple assignments at a time with little direction
Ability to read, interpret, and communicate technical specification requirements
Possess written and oral communication skills necessary to interact with all levels of the organization
Adept in soliciting facts and opinions from all team members, and creating a constructive and open environment for sharing data
Capable of making a decision and communicating to team members why certain facts or recommendations prevailed over others
Strong Project Management skills with the ability to lead in high visibility situations
Ability to identify and mitigate risk (Intelligent Risk-Taking) to achieve positive outcomes
Able to promote quality acumen through coaching and mentoring cross functional peers
Strong team player with ability to influence and support cross functional team activities to improve product/process quality
Proficient using common software (MS Word, Excel, Power Point, Minitab, etc.)
As an Equal Opportunity Employer, Honeywell is committed to a diverse workforce

225

Senior Quality Engineer Resume Examples & Samples

15%- Provide material review dispositions for nonconforming materials, parts and equipment. Perform corrective/preventive action and root cause analyses to reduce or eliminate nonconformances
15% - Analyze and compile performance reports and process control statistics in order to determine and improve process capability or product quality
10% - Develop processes and systems that ensure the quality, reliability and system safety of company procured products and services. Analyze contractual and specification requirements for the development or modification of methods, procedure, and metrics needed to ensure that quality standards and practices are attained. Perform process audits

226

Senior Quality Engineer Resume Examples & Samples

Minimum of 3 years in quality engineering and automotive experience preferred
To be capable of writing process inspection control plans and process inspection
All candidates may submit a resume to Johnson Controls at 2541 7th Street

227

Senior Quality Engineer Resume Examples & Samples

Define, drive, implement and support continuous effort of Quality Engineers in each scrum team for
5+ years of experience as a Sr. QE and Senior Test Automation Engineer and a bachelor’s degree in computer science or related field
A plus will be experience working with Agile Scrum teams including participation in the following: sprint planning, daily stand-up, sprint retrospective, sprint review, backlog grooming, review delivery readiness, etc
Experience using and configuring for CI a full stack of automated test for functional UI, performance and security testing
Good understanding of Object Oriented programming
Experience in implementing testing architecture for large scale distributed software platforms
Good understanding of Testing Frameworks and Test Design Patterns
Experience of working and implementing Continuous Integration environments
Experience in implementing device, cross browser and OS’s testing solutions
Testing Frameworks like: JUnit, TestNG
Test Design Patterns like: Page Object Model, Page Factory, Robot Framework
Release, Defects and Test Management tools like: JIRA, QC/ALM, TestRail, QA Complete, Test Lodge
Experience of working within Continuous Integration environments using tools like: Jenkins, Bamboo, Teamcity etc
Cloud device automation on platforms like Sauce Labs

228

Senior Quality Engineer Resume Examples & Samples

Develops quality testing approaches to gain optimum test coverage, and evaluates test results
Creates automated test scripts & scenarios based on use cases. Analyzes results
Continuously looking for ways to improve testing coverage and testing efficiency
Assists in product planning and product readiness decisions
Reproduces bugs, assesses impact to customer and problem scope
Engaged with fellow scrum team members to achieve product delivery goals
Takes pride and ownership in his/her work every day
Bachelor's degree or equivalent level of experience in computer science/information technology or business studies
At least five years’ experience in software development. Experience with multiple product release cycles
Sound functional knowledge in the areas of manufacturing, distribution, or finance domain
Experience with automated testing tools, proven ability to learn and share
Proficient in problem solving while keeping in mind multiple scenarios
Good knowledge of how the product should behave across many major functional areas
Able to clearly engage in communication around functionality and product issues
At least one year of customer support experience a plus
Exposure to Agile software development methodologies a plus
Enthusiastic about learning, innovating, and contributing to team goals

229

Senior Quality Engineer Resume Examples & Samples

Have a fundamental understanding of quality philosophies, principles, systems, methods, tools, standards, organizational and team dynamics, customer expectations and satisfaction, supplier relations and performance, leadership, training, interpersonal relationships, improvement systems, and professional ethics
Have a basic understanding of the audit process, including types of audits, planning, preparation, execution, reporting results, and follow-up
Develop and implement quality programs, including tracking, analyzing, reporting, and problem solving
Plan, control, and assure product and process quality in accordance with quality principles, which include planning processes, material control, acceptance sampling, and measurement systems
Plan, control, and assure product application, including design, manufacturing and construction
Have basic knowledge of reliability, maintainability, and risk management, including key terms and definitions, modeling, systems design, assessment tools, and reporting
Acquire and analyze data using appropriate standard quantitative methods across a spectrum of business environments to facilitate process analysis and improvements
Understand risk analysis philosophies and methodologies and their applications. Understand readiness processes and requirements
BS degree plus a minimum of 6 years of relevant experience or MS degree plus 4 years of relevant experience. Equivalent experience may substitute for education
Solve problems with variable inputs and concrete solutions

230

Senior Quality Engineer Resume Examples & Samples

Day to day management of Line Support, Goods Receiving Inspection and Lead Auditor Team Members
Management by Objectives of the Quality Team pursuing continuous improvement of Quality Systems, Processes and outputs
Rapid and robust investigation, containment and resolution of Supplier related defects
Leading Problem Solving Activities utilising a Cross Functional Team Approach across departments
Drive adherence to ISO Quality Management System throughout the business
Ensure accurate Supplier Reject Records and drive supplier improvements including Esmp escalations on the JCB Supplier Problem Management System and Supplier Clinics
Management of 3rd Party Divert Provider ensuring problem containment
Develop an CMM Audit Plan for major Welded Assemblies

231

Senior Quality Engineer, NDT Level Resume Examples & Samples

Audit and surveillance of quality systems and processes
Assessing potential new suppliers
Monitoring suppliers to ensure flow down of AR requirements to sub-tier suppliers
Promoting and assisting supplier continuous improvement
Physical hardware inspection, acceptance and release
Validating and reviewing supplier first article inspections
Product integrity reviews (physical and documentation)
Review and approval of supplier technique sheets, ensuring compliance to AR specifications and drawing requirements
50% - Review supplier-submitted NDT technique sheets for compliance to AR-Los Angeles specifications and drawing requirements. Coordinate with suppliers on the development and approval of these technique sheets. Prepare necessary reports
40% - Manage site NDT supply base by monitoring suppliers to ensure flow down of AR requirements to sub-tier suppliers, audit existing NDT suppliers and assess potential new NDT suppliers for their ability to meet site requirements
10% - Review process specifications, in-house technique sheets, etc
Hands-on working experience in a manufacturing environment and a corresponding understanding of manufacturing processes is essential
Experience with auditing practices and Process Certification is desired
A demonstrated proficiency with a variety of NDT inspection techniques and equipment along with a working knowledge of blueprint reading and interpretation is required
Knowledge of industry NDT standards (ex. NAS410, ASTM 1742, ASTM 1417, ASTM 1444, AMS-STD-2154, etc...) is requisite
Must have experience in at least two of the following NDT methods: Radiography (RT), Ultrasonic Testing (UT), Fluid Penetrant Inspection (FPI), Eddy Current (ET), or Magnetic Particle (MT)
Certifications: The ideal candidate would have multiple Level 3 certifications; RT, UT and FPI preferred. At least one Level 2 certification is required
Candidate must meet requirements of NAS-410
Must have demonstrated excellent interpersonal, written and verbal communication skills, as well as the ability to work well in a team environment
Must possess strong computer skills and be well-organized
Extensive travel is required. Position requires responding to customer needs and may include weekend work
Auditing experience/certification desired

232

Senior Quality Engineer Resume Examples & Samples

Design, analyze and evaluate quality assurance systems
Act as Principal Investigator on Company-sponsored task forces and organize & direct technical efforts of a team of engineers whose expertise encompasses various disciplines
Support other groups involved in such matters as quality related sales efforts and complying with quality standards
Assume major responsibility for the preparation of quality assurance economic studies, specifications, purchase related documents, technical reports, proposals, licensing, safety, and related documents
Plan, perform or assist in complex supplier quality evaluations, audits, surveillance, document reviews and unique problem analysis
Operate independently, representing the quality organization at major meetings or conferences to resolve important issues or to plan work, typically involving innovative approaches & influencing decisions
Liaison among various groups, suppliers, customers and regulatory authorities to accomplish quality programs involving such technologies as Non-Destructive Testing [NDT], metrology, statistical methods, fabrication techniques, quality codes and regulations
Provide technical consulting services, seek opportunities and implement measures to improve operations & customer satisfaction
Evaluate corrective action requests and maintain associated database
Manage quality related manufacturing information changes and associated database
Drive ABB Customer Complaint Resolution Process and maintain associated database
Evaluate quality discrepancy reports for trends and maintain associated database
Initiate & evaluate effectiveness of incoming inspections
Support assembly line "part" quality concerns & decisions
Review & update Plant procedures
Actively participate in Transformer Bushing Teardown
Evaluate returned parts for root causes & corrective action
Develop course of action to resolve quality issues including task assignment & follow up
Perform internal audits as directed by ISO 9000:2008 criteria
Assignments require diversified knowledge of engineering, manufacturing and related functions & in-depth knowledge of quality assurance programs, procedures, and regulatory agency guidelines
Requires excellent communication skills to negotiate effectively with suppliers, customers & internal groups, and ability to coordinate activities involving diverse technical disciplines
Requires ability to develop innovative solutions to problems & make decisions regarding quality matters that may significantly impact contracts
Extensive experience working with electrical components is highly preferred
Current Six Sigma certification is a plus; Six Sigma Black Belt (SSBB) certification is highly preferred
Recent experience working with Continuous Improvement and/or Process Improvement methodologies – especially Lean Manufacturing, and/or Six Sigma (e.g. Statistical Process Control [SPC], Kaizen, 4Q, DMAIC, Gemba/Genba, Root-Cause Analysis, etc.)
Recent professional experience working in Quality Engineering functions, especially in a manufacturing environment
Professional certification by the American Society of Quality [ASQ] – CQE (Certified Quality Engineer] is heavily preferred
Membership in the IEEE (Institute of Electrical & Electronics Engineers) is a plus
Proven ability to work within cross-functional teams

233

Senior Quality Engineer Resume Examples & Samples

6+ years of experience with 4+ years of relevant experience (i.e., developing applications in Android/other mobile environment) Native android
Experience in Android UX: Custom UI Development and deep knowledge about available UI widgets
Hands on experience in JAVA & Android API’s: Network (e.g Socket, HTTP, FTP), File I/O, Content Provider
Strong JAVA OOAD knowledge, JAVA basics, Collections APIs
Strong understanding of design patterns
Excellent Debugging (including ADB debugging), Profiling, Refactoring & Optimizing code base, tuning the Android applications skills
Excellent in handling Exceptions, Crashes, Memory issues handling, Performance tuning & Concurrency
Strong focus toward code quality
Excellent Collaboration skills
Strong understanding of memory management, android lifecycle management
Experience in Agile Software development

234

Senior Quality Engineer Resume Examples & Samples

Define technical strategy for next-generation Web UI framework
Evaluate new web technologies in their alpha/beta releases
Collaborate with UI/UX design team and quickly implement prototypes for desktops and mobile browsers
Optimize web applications to maximize speed and scale
Experience in Agile methodologies
Experience building complex UI applications using latest technologies that have been successfully delivered to customers
Min 5+ years of experience in desktop and Mobile based UI interface development
Strong & hands on knowledge in HTML5, CSS3 , Jquery/ Jquery Mobile , Bootstrap, Ajax
In-depth understanding of Object Oriented JavaScript/Typescript Programming using Design Patterns
Strong Knowledge with data binding concepts of MVC like Angular JS or Backbone JS
Ruthless commitment towards code quality
Experience in C++/VC++ based software development
Android/ IOS hybrid application development experience
Experience in REST API's
Excellent collaboration skills
Very approachable mentor and great influencer for the team, technically

235

Senior Quality Engineer Resume Examples & Samples

Leads integration of contractual and Boeing Quality Management System requirements into all aspects of proposals and program processes and documentation
Provides interpretation of complex requirements
Develops quality metrics, design and production certification plans for large programs to ensure compliance with contractual, Company and regulatory requirements
Develops Quality criteria to support supplier selection activities. Leads various reviews to ensure quality attributes are incorporated into product designs
Assists in development of new standards repairs for non-conformances. Analyzes non-conformance trends to evaluate effectiveness of corrective actions
Develops and implements corrective actions

236

Senior Quality Engineer Resume Examples & Samples

Ability to work 1st or 2nd shift as required
Assure clear identification, physical control and competent disposition of defective material
Demonstrated ability to lead cross functional process improvement teams
Ability to exercise sound judgment and apply decisions
Proficiency at preparing and presenting information to upper management and Customers
Participate in or lead CCB, FRB, PMAB, PCB, and MRB boards
Proficient at preparing and presenting clear and concise presentations to suppliers, Customers, and management　
Make improvements by analyzing data for targeted processes
Working knowledge of Raytheon RCAS or a similar proven closed - loop corrective action system
Strong written/verbal presentation skills
Exceptional interpersonal skills and a professional demeanor　
Possess an existing Secret Clearance or ability to obtain a Secret Clearance
Raytheon Six Sigma Specialist or Industry Six Sigma Greenbelt Certification
Required Education (including Major)
Bachelor's Degree (BS) in Engineering, Science, Mathematics, Business, or Quality Assurance

237

Senior Quality Engineer Resume Examples & Samples

Perform functional, regression and load testing of applications
Test front-end Web applications as well as back-end infrastructure
Communicating with local and foreign stake holders and business
Bachelor’s degree or above
Proactive team player with the ability to work in global dynamic environments
Software Development experience using language like Java, Ruby, Python, etc
Knowledge of Web Server, HTTP protocol, XML, Basic Networking

238

Senior Quality Engineer Resume Examples & Samples

Bachelor of Science in Engineering, or equivalent experience
9+ years’ experience in Quality Assurance
Knowledge of ISO9000:2008
Working knowledge of industry, military standards and specifications
Experience in defense or electro-optics industry preferred
Knowledge of AS9100, Lean 6-Sigma preferred
Experience leading successful CMMI for Development process institutionalization preferred
Must be a US Citizen with the ability to obtain a US Secret Clearance

239

Senior Quality Engineer Resume Examples & Samples

Read and understand high level product description or requirement documents, design elements and propose test plans and test cases to perform system, functional, integration and end user level testing of software work products using .Net technologies
Development of needed test scripts and test harness to perform the test function
Performing the test function on new or modified software and report failed test cases in the bug tracking system
Document work, record and produce test reports
Plan, estimate, organize and execute assignments with very little or moderate supervision
Present work to team for review or other purposes
Participate in reviews of work done by peers and provide constructive feedback
Be contemporary, by adopting technological and market evolutions
Support developers and junior engineers on need basis
Must have been part of large implementations and gone through major test cycles
Must have a working experience of about 3 years in relevant areas
Must have served in an organization where agile practices are in use
HTML5

240

Senior Quality Engineer Resume Examples & Samples

Reviews inspection criteria, inspection methods and procedures to assure acceptable quality standards that meet the needs of the business
Investigates product complaints and directs the activities required to assure the timely implementation and documentation of corrective action
Monitors quality trends and conducts technical and statistical investigations on quality problems, reporting the results and recommendation in a timely manner
Prepares for and participates in internal and external audits and implements corrective action to audit observations to prevent recurrence
Participates in the Material Review Board meetings and takes the lead with other functional groups to determine root cause failure and implement actions to prevent recurrence
Supports operational teams responsible for investigating and providing corrective action for NCRs and/or CAPAs
Serves as Quality representative for design transfers or technology transfers
Leads the development of Process FMEAs
Leads Quality Engineering Projects to improve Quality System and Procedures (e.g., defect analysis, control charts, data analysis, lead Quality and Continuous Improvement Projects)
Develop or assist in the development of Process Validation documentation such as protocols and reports (IQ, OQ, PQ) and performing statistical analysis as required
Conduct other Quality Control Projects as assigned by the QA Manager
Reviews all documentation related to product quality such as test procedures, raw material, specifications, operational procedures and approves as appropriate to ensure product quality
Improves systems, monitors performance, and identifies skills, training and capabilities needed
Supports operational teams responsible for investigating and providing corrective action for NCR’s and/or CAPA’s
Assures plant personnel are compliant to training requirements. Complies with the cGMP’s, Quality Standards and established policies and/or procedures
Review DHR documentation for compliance and release of components and finished product
Bachelors Degree in Engineering or Technical Science with 5-8 years relevant experience or MS Degree in Engineering or Technical Science with 2-6 years relevant experience
Experience in Quality Engineering disciplines including product/ process validation, applied statistics, and technical problem solving
Strong Compliance understanding especially in post-market activities (including complaints, failure investigations, and CAPAs)
Strong experience in Risk Management and transfer activities
A high level of competence in Quality Technology, statistical techniques, and six sigma tools including: sampling plans, process capability analysis, gage R&R, hypothesis testing, analysis of variance, regression, and design of experiments
Relevant medical device experience in Class II/III environment preferred
Excellent problem solving, interpersonal communication, presentation, statistical analytical, computer, and project
Management skills
Applied Knowledge of the requirements of FDA QSR, ISO13485and ISO 14971:2012
Must have a positive attitude with excellent communication, negotiation and interpersonal skills to maintain a team oriented environment and maintain critical relationships with contractors, suppliers and investors
Ability to thrive under challenging deadlines and in an energetic environment
Must have a desire for achieving excellence in customer satisfaction, process and product quality and reliability
Ability to manage multiple projects, communicates updates, and meets milestones in a timely fashion
Experience with Statistical software (Minitab, etc.) and MS Project software preferred
Proven leadership skills in a fast paced environment

241

Senior Quality Engineer Resume Examples & Samples

A minimum of 5+ years of success in technical and Client facing roles in the Payments or client facing industry
Functional experience in bankcard operations, preferably Visa, supporting highly complex clients and/or services
Working knowledge of payments network and processing services – message routing, STIP, clearing and settlement
Working knowledge of Client business drivers for their operations and processing businesses and how it relates to their programs
Strong oral and written communications
Complex analytical analysis
Portuguese Speaker is a plus

242

Senior Quality Engineer AWS Elemental Live Transcoding Resume Examples & Samples

5+ years of software development experience, preferably in a testing role
A BS in math, science, or an engineering discipline, or equivalent experience
Strong attention to detail and a zeal for thoroughness
Proven track record of producing high quality work
Proficiency in at least one scripting language under Linux
Media software experience
Experience with AWS services
Proficiency in C/C++
Experience with virtualization and/or containerization

243

Senior Quality Engineer Resume Examples & Samples

Train associates, suppliers, and contract personnel in Six Sigma techniques, Manufacturing Process Control, variation reduction, etc
Bachelor’s degree in engineering, materials, supply chain, management, business or technical discipline. In lieu of Bachelor’s degree, at least 13 years of related technical or business experience
5 years of experience in manufacturing/assembly operations, quality, engineering (design or manufacturing), and materials/procurement; these areas may be replaced by related military experience
Experience in leading teams focused on problem solving and improvements
Good communication skills with the ability to provide a clear vision of the strategy and processes for key stakeholders
Additional Qualifications
3 years of experience working with suppliers preferred
Additional experience or training in RCCA, Process Mapping, FMEAs and Control Plans or APQP/PPAP preferred

244

Senior Quality Engineer Resume Examples & Samples

Have knowledge with ISO9001 & ISO14001 standard with practice experience
Six Sigma GB is plus
Basic reading and writing in English

245

Senior Quality Engineer Resume Examples & Samples

More than 5 years quality assurance or manufacturing experiences in electric, automobile, aerospace industries
Strong logical thinking and problem solving skills (Mandatory), be familiar with 8D, 5 why analysis and other quality tools esp. FMEA, PCP
Fluent English communication ability
Bachelor degree above, science or technology preferred

246

Senior Quality Engineer Resume Examples & Samples

Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements
Lead, coach, and mentor non-exempt and entry level exempt personnel
Appropriately document experiment plans and results, including protocol writing and reports
Lead process control and monitoring of CTQ parameters and specifications
Lead the investigation, resolution and prevention of product and process non-conformances
Lead in the completion and maintenance of risk analysis
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
BS degree in Engineering or Technical Field or equivalent experience 5+ years’ experience
Advanced computer skills, including statistical/data analysis and report writing skills
Ability to leverage and/or engage others to accomplish projects
Ability to travel approximately 10%
Demonstrated supervisory experience preferred
Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
ASQ CQE or other certifications preferred

247

Senior Quality Engineer Resume Examples & Samples

Primarily responsible for: Risk management, Risk Table creation & Analysis, FMEAs, Quality Plan, Literature Review, Device Master Record, Quality Training Plan and Technical File
Product risk assessment as per ISO14971
Primary participant in new supplier selection, validation, and contract development. Assists vendors in resolving manufacturing and quality issues as required
Partners with the operations team to develop and maintain a robust internal and external supply chain
Contribution examples include the performance of supplier audits, risk assessment/mitigation, and coaching
Develop procedures for incoming, in-process and final inspections for new product development
Assists and mentors the unit quality engineer in the trending and analysis of quality data (e.g. complaints, Tech Support trouble tickets, Pareto charts, scrap, warranty return rate, etc.) and provides guidance to address issues as appropriate
Authors and reviews procedures to ensure GMP and ISO 13485 compliance
Lead product quality related projects. Supports the business in addressing and solving quality problems
Conduct internal audits & participate in corporate and FDA audits
Support process validation programs for new product development
Work with cross-functional/cross –cultural teams to develop regulatory guidelines and procedures
Provide inputs for NPDP for adherence to QMS and Good Documentation practices
Work with engineering & manufacturing teams to develop robust verification test strategies to ensure product safety and reliability

248

Senior Quality Engineer Resume Examples & Samples

4 year degree in engineering or associated scientific discipline
Minimum of 6 years experience in Quality or Design Engineering position
General knowledge and understanding of Critical to Quality principles with proficient understanding of DFSS, DMAIC, and CPM tools and methods
Proficient at problem solving and analytical techniques such as Is/Is Not Matrix, Fish Bone Diagram, Concentration Diagrams, Contradiction Matrix and Design of experiments (DoE)
Proficient in use of statistical analysis and associated tools (e.g. Tableau, Minitab, Statistica)
Ability to critically review and interpret technical documentation
Ability to lead team members and transfer knowledge of CtQ and other Quality tools and techniques

249

Senior Quality Engineer Resume Examples & Samples

Develops and initiates standards and methods for inspection, testing, and evaluation of both manufactured and purchased products
Devises sampling procedures and designs and develops forms and instruction for recording, evaluating, and reporting quality and reliability data
Establishes program to evaluate precision and accuracy of production equipment and testing, measurement, and analytical equipment and facilities
Provide and conduct training and prepare, review, and issue written instructions and procedures to operators on all matters affecting quality
Analyze scrap and rework data for significant issues. Prioritize issues and lead a corrective action team to investigate and correct root causes to these issues
Coordinates Advance Quality Planning (AQP) activities for new products within responsible processes
Develop control plans, as appropriate, based on FMEAs, process capability, and recognized manufacturing limitations
Ensure customer specific requirements are incorporated into our processes and/or procedures as appropriate
Develops and manages the quality system audit process including product, process, and system audits
Defines quality measurements to align assigned processes with strategic business objectives
Designs measurement systems and tools to evaluate performance characteristics (e.g., gauges, fixtures, templates, gauging methods
Trains others in the application of quality tools (e.g., 8D, DOE, Pareto analysis, Paynter charts)
Applies reliability data to remedy known systemic weaknesses

250

Senior Quality Engineer Resume Examples & Samples

Able to develop technical solutions to a variety of problems of moderate scope and complexity
Organized and able to manage numerous tasks and projects simultaneously to meet target dates
Able to use project management skills to initiate and lead improvements of a tactical nature
Understands and able to interface with other segments of the order fulfill process
Experience testing and troubleshooting hardware and/or software
Experience with system level testing and troubleshooting
Understanding of networking devices and networking applications
Excellent troubleshooting and root causing skills
Perform analysis on customer returns for root cause
Ability to apply logic to limited data sets to identify defect patterns, failure modes, and root cause
Experience with qualifying and troubleshooting supplier/vendor processes
Minimum 2-4 years in Quality or Technical Field with Bachelor’s Degree or equivalent defined as a minimum of 4-6 years in Quality or Technical field (or 2-4 yrs. with Associates Degree)
ASQ Certified Quality Engineer, Certified Reliability Engineer or Black Belt and demonstrated ability to apply the specific Body of Knowledge

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15 Senior Quality Engineer resume templates

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Senior Quality Engineer Resume Examples & Samples

Senior Quality Engineer Resume Examples & Samples

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Senior Quality Engineer Resume Examples & Samples

Senior Quality Engineer Resume Examples & Samples

Senior Quality Engineer Resume Examples & Samples

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