Principal Quality Engineer Resume Samples

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K Weissnat

Kathleen

Weissnat

8915 Quitzon Park

Chicago

+1 (555) 611 7469

8915 Quitzon Park

Chicago

Phone

p +1 (555) 611 7469

Experience Experience

Los Angeles, CA

Principal Quality Engineer

Los Angeles, CA

Bergnaum, Adams and Johnson

Los Angeles, CA

Principal Quality Engineer

Work with development, product management and other testers to create test cases and automate testing
Leads the product risk management process, including the development and maintenance of risk management files
Identifies and manages risk throughout the development process with the use of FMECA and/or other risk management tools
Develop and oversee Executive Reports provided to management regarding status of Quality issues
Participate in new product development initiatives by providing quality engineering support to assigned projects
Applies statistical sample size calculations to work for quality determination on projects of intermediate scope/complexity
Provide QS support in Product transfers and new products development

New York, NY

Principal, Quality Engineer, Audience Studio

New York, NY

Conroy, Cormier and Stamm

New York, NY

Principal, Quality Engineer, Audience Studio

Design, develop and execute automation scripts using open source tools
Perform thorough regression testing when bugs are resolved
Create detailed, comprehensive and well-structured test plans and test cases
Develop and code the testing services that is core to Audience Studio, under the leadership of the Chief Architect
Identify, record, document thoroughly and track bugs
Estimate, prioritize, plan, and coordinate testing activities
Solid knowledge of SQL and scripting

present

Houston, TX

Senior / Principal Quality Engineer

Houston, TX

Welch Inc

present

Houston, TX

Senior / Principal Quality Engineer

present

Provide support to the Corporate Quality Risk Management program including training materials, risk tool development, facilitation and guidance to all Specialty Care (Biologics) sites in accordance to the Quality Risk Management standard
Organize and lead cross functional problem solving teams through root cause identification, verification and corrective action steps including preventive actions
Track quality issues and test failures, working with component owners, suppliers and other stakeholders to facilitate their fast and effective resolution
Provide training to the organization on standardized risk tools such as Failure Mode and Effect Analysis (FMEA), Preliminary Hazards Analysis (PHA), Hazard Analysis and Critical Control Points (HACCP) and other customized risk tools
Mentor and train engineers in the use of quality tools, work to propagate and champion best practice across the project and department
Communicate teams’ progress to stakeholders, management and unit leaders
An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes

Education Education

Bachelor’s Degree in Engineering

Liberty University

Bachelor’s Degree in Engineering

Skills Skills

Ability to coach and mentor team members and transfer knowledge of CtQ and other Quality tools and techniques
Thorough knowledge of Critical to Quality principles with understanding of DFSS, DMAIC, and CPM tools and methods
6) Strong automation experience (including GUI), knowledge of
The incumbent is expected to achieve and maintain certification in one or more of the following disciplines: Quality Engineer, Quality Auditor or other ASQ certifications within 3 years of hire
Sound knowledge / experience of inspection of Hardware from component level through to sub-assembly and final assembly configuration (COTS / Surface Electronics / Mechanical systems)
Knowledge of Web Server, HTTP protocol, XML, Basic Networking
Identifying and driving process improvement and testing efforts to ensure delivery of high quality product
Experience testing Web and Database applications and working knowledge of Unix/Linux, SQL
Experience / knowledge of Configuration Management within a design / manufacturing environment
Coordinating creation and maintenance of test data, test plans, test automation and deliverables

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Principal Quality Engineer Resume Examples & Samples

10-12 years of experience in a technology company
Proficiency in complex systems that include electronics, software, fluid and mechanical components
5 years minimum in beverage or fluid dispensing related industry with emphasis on dispensing quality
Must have a minimum of 10 years total experience in manufacturing and quality with at least 5 years working as a quality or test engineer in a PLM environment
2+ years of knowledge of reliability principals and testing
Experience working with geographically diverse teams and leading teams to design and build quality and reliability into production
Ability to provide risk mitigation strategies

Principal Quality Engineer Resume Examples & Samples

A minimum of a Bachelor's degree is required, a degree concentration in Engineering, Life Science, Physical Science or a related field is preferred; an advanced degree is an asset
A minimum of 8 years of experience in Product/Process Quality and knowledge of validation processes in a regulated environment is required. Experience in the medical device industry is strongly preferred
Knowledgeable of medical devices product performance and manufacturing is preferred
Knowledgeable on validation related regulations is required
Ability to apply principles of root cause analysis and statistical analysis to determine common vs. special causes is required. Ability to develop CAPA plans preferred. Ability to apply lean process concepts leading to improvements in quality processes a preferred. Good understanding of design control process including design validation/verification, process validation, design transfer and DHF requirements is preferred
Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, graphs, charts, diagrams). Ability to deal with a variety of abstract and concrete variables. Ability to interpret information furnished in written, oral, or diagram form
Influencing skills, communication skills, presentation skills, listening skills, interpersonal skills, negotiating skills, problem solving/decision-making skills, ability to set priorities and achieve objectives, practical application ability and/or working knowledge of project management, cost/benefit analysis, technical writing, Good Documentation Practices, Management of multiple priorities are required
Demonstrated Project management skills, such as supporting multiple projects simultaneously are required
This position will be located in West Chester, PA and will have up to 10% travel both domestic and international

Principal Quality Engineer Resume Examples & Samples

They may contribute inventions, new designs or techniques which are materially significant in the solution of important problems
Principal Engineers will act as a mentor to more junior staff and advise top management on technical matters
This Principal Quality Engineer will gain visibility to needs across all J&J businesses and lead innovative improvements designed to increase process capability, reduce risk, and grow organizational QE capability
He/she will utilize Quality Engineering tools and methods for the effective and efficient development, transfer, and maintenance of products/processes throughout the End-to-End Value Chain
He/she will utilize Quality Engineering principles and problem solving skills to develop and optimize products/processes and ensure effective risk management to prevent unanticipated failure modes
The Principal Quality Engineer will coach and mentor other engineers
This position will lead efforts to drive more effective process validation activities
A minimum of a Bachelor’s Degree, preferably in Engineering or related technical field is required
Generally requires 5+ years related experience
Experience with a proven track record of implementing appropriate risk mitigation is required
Advanced Technical Training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc. is required
The ability to perform "hands on" troubleshooting and problem solving is required
The ability to think and act with agility while providing sound judgment is required
Excellent technical understanding of manufacturing equipment and processes is required. Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred
A thorough understanding of GMP/ISO regulations and validation regulations is preferred. Strong mentoring, coaching and leadership skills are required
Demonstrated project management and project leadership abilities are required
This position can be located anywhere in the world and will require travel

Principal Quality Engineer Resume Examples & Samples

A minimum of a Bachelor's Degree in a related technical discipline is required; an advanced degree is preferred
A minimum of 8 years of experience in a regulated industry is required
Previous experience in pharmaceutical and combination product industry is required
Knowledge of 21 CFR Part 4 and 21 CFR Part 210 – 211 is required
Experience working in Med Device is highly desirable
Strong working knowledge of the drug GMPs and QSR quality requirements is required
Strong quality engineering skills with a proven track record in design verification/validation, process verification/validation, and design/process failure modes and effects analyses are all required
Strong working knowledge of chemistry and material science is preferred
Blueprint literacy including GD&T is preferred
Knowledge of process and design excellence tools is strongly preferred, certification is a plus
A proven track record implementing Quality System improvements to meet compliance is highly desirable
Excellent problem solving, decision-making, and root cause analysis skills is required
This position will be based in Raynham MA, and will require up to 10% travel.Validation

Principal Quality Engineer Resume Examples & Samples

7-10 years quality engineering experience, preferably in a Class II or III medical device environment
Experience in design control of electro mechanical medical devices
Strong knowledge of design control, 21 CFR820, ISO13485, ISO14971 and other applicable FDA and ISO regulations and laws
Working knowledge of statistics and statistical packages (Minitab)
Requires the ability to perform independently & as part of a team
Must be able to influence & negotiate with people & resolve issues
Ability to make rational, objective & appropriate decisions relating to company & department needs & resource allocation
Ability to communicate decisions across a wide spectrum of the organization
Must have 7-10 years of experience in medical device design control in electro-mechanical products
Experience in managing outsourced projects

Principal Quality Engineer Resume Examples & Samples

Monitors and ensures compliance with company policies and procedures (e.g. compliance with FDA, BSI, etc.)
Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross function teams
Preparation of QA data reports ( FPY,FYRR, OOBF). Responsible for meeting Quality goals
Responsible for overseeing failure analysis, documenting failure analysis and recommending corrective action for instrument complaint, service, production and receiving inspections issues. Provides coaching on failure analysis techniques to junior engineers
Support Development/Operations Engineering and Manufacturing to resolve technical issues and implement corrective and preventive action for products
Manages Quality Notifications (QN) for non-conforming product and deviations. Monitors Quality Notification progress and works with cross-functional team to complete QN per requirements
Manages Ship Holds, assesses and recommends the need to put product on hold; generates Ship Hold notification; works with teams on failure investigation and risk assessment related to the hold
Member of the Material Review Board, collaborates with engineering, manufacturing and purchasing on the disposition of non-conforming product
Reviews and approves test and validation documents, receiving inspection requirements, sampling plans, and Change Orders for product and process changes. Initiates change orders to correct drawings, release new parts, change specifications, and Quality System Procedures
Member of the team responsible for supporting high visibility quality projects
Writes detailed Risk Assessments, updates Process Hazard Analysis, and presents the analysis to the Risk Management Board
Mentors other Quality Engineers and provide guidance on regulatory guidelines
Leads teams or projects; shares expertise
Bachelor's degree in a technical field with minimum 8 years of experience in the Quality Engineering field, or minimum of 15 years of work experience as a Quality Engineer in medical industry or other highly regulated field
Previous experience in a manufacturing environment as opposed to R&D
Direct experience with medical devices, instrumentation and/or disposables in a regulated environment
Expert in Quality Engineering discipline, including statistics
Demonstrates knowledge of FDA/ISO requirements
Prior experience supporting a manufacturing/service operation
Working knowledge of DMAIC/Six Sigma problem solving process

Principal Quality Engineer Resume Examples & Samples

Demonstrates intermediate knowledge of quality engineering policies, principles and best practices
Demonstrates intermediate knowledge of FDA/ISO requirements
Applies intermediate understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to support work with little or no supervision
Comprehensive knowledge in software development, including knowledge of software engineering, as well as test processes and methods
Able to pull reports (queries), interpret trends and make recommendations for improvement to existing tools
Uses comprehensive expertise to help improve and streamline the software quality or development process
Review complex test cases/scripts and interprets/analyzes results to report, communicate, and work through issues with software engineers
Can apply comprehensive understanding of the inter-workings of the application code under test
Participates in conducts code reviews and design reviews
Applies software engineering knowledge to tasking (eg. code and detailed design reviews, low-level white box testing, etc.)
Applies knowledge and skills to a wide range of standard and non-standard situations
Usually determines own work priorities
Acts as a resource for colleagues with less experience
Qualified candidates will have a Bachelor’s degree in a relevant degree field (engineering) and minimum 5 years’ experience with emphasis on R&D development, Software Quality Engineering and Design Control
Experience with Software development experience within a regulated environment will be recommended
Strong background in software is preferred
Thorough understanding of the risk management and quality by design is preferred
Attentiveness to details with strong organizational skills
Ability to work proactively and independently
Ability to multi-task and efficient in time management
Excellent verbal communication and interpersonal skills with the ability to work in a team environment
Proficiency in Excel, Word, and other desktop/general business systems

Principal Quality Engineer Resume Examples & Samples

Team-oriented with strong interpersonal and situational management skills
Results and solutions oriented mindset
Able to thrive in fast paced environment within multiple teams and on multiple tasks
Technical Acumen – manufacturing, process validation, statistical techniques, computer skills (Microsoft Office products)
Molding experience is strongly preferred
Bilingual speaking strongly preferred
Requires a technical degree with a minimum three to five (3-5) years of experience in the following areas: Quality/Supplier Quality Engineering in the medical device field, leading quality system audits, medical device manufacturing, design transfer, process validation (IQ, OQ, PQ), statistics and sampling methods, and CAPA root cause analysis
Strong familiarity with regulatory requirements (FDA QSRs, ISO 13485, MDD, CMDR, J-PAL), risk management (ISO 14971), statistical software (MiniTab), and Six Sigma Methodology
SJA

Principal Quality Engineer Resume Examples & Samples

May act as mentor to less experienced team members
Applies statistical sample size calculations to work for quality determination on projects of intermediate scope/complexity
Applies intermediate understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to support work with minimal supervision
Writes test protocol, tests, collects data, and writes reports to validate against plan to ensure product is used as intended
Bachelor's degree strongly recommended, advanced degree preferred
4-6 years experience
Experience in respiratory care or with the manufacture of electromechanical devices is desirable
Experience or certification in Lean Six-Sigma highly desired

Principal Quality Engineer Resume Examples & Samples

Ensure site suppliers (Contract Manufacturers, API, Sterilization, Raw Materials, Components and high risk service providers) are compliant with Local and Federal regulations as well as B+L Quality Standards
Develop and implement Quality agreements between B + L and contract sites
Provide and implement solutions to Supplier and CMO issues that arise which could impact compliance to applicable regulations and Bausch & Lomb Quality Systems (including escalation to Leadership)
Ensure appropriate quality agreements, standards and joint venture agreements are in place for Suppliers and CMOs
Development of strategic and tactical goals based on evaluation of published regulatory and industry trends as well as the evaluation of the relevant quality metrics of the Tampa Organization
Responsible for the maintenance and development of the internal and external audit programs
Maintain and build effective and professional business relationships with internal customers (Site Quality, Procurement, Operations), Suppliers and CMOs
5 – 10 years in Pharmaceutical industry, with 5+ years in Quality Assurance as an internal or external auditor. Strong computer skills, relationship building skills, excellent communication (verbal and written) skills. Experience working in a changing environment and fast-paced organization as a member of cross-functional teams (Quality, Operations, Regulatory Affairs and Regional) a must

Principal Quality Engineer Resume Examples & Samples

Reviews new and modified product design and manufacturing processes for quality characteristics, including manufacturability, serviceability, testability, reliability and conformance to product and quality system requirements
Leads the product risk management process, including the development and maintenance of risk management files
Qualifies component and service suppliers, conducts supplier audits and ensures that appropriate supplier quality controls are implemented
Analyzes data and applies knowledge of engineering principles and practices to implement continuous improvement projects
Monitors internal and external standards changes related to quality engineering requirements and develops and implements compliance strategies
Provides guidance to R&D, Operations and Quality on design and production/process controls, risk management, root cause analysis, validation, and the application of statistical methods
Designs, selects, and applies appropriate statistical methods
Reviews the application of statistics commensurate with the risk
Owns the process of statistical techniques in their respective area
Creates and owns internal statistical technique training material for SME and functional area personnel
Other responsibilities as required or assigned by manager
Bachelor's degree in a life science, engineering, physical science or related discipline
At least 8 years of experience as a Quality Professional in an FDA-regulated industry, with at least 5 years in the Medical Device industry
In-depth knowledge of design control, risk management, production and process controls and applicable regulations (i.e., ISO 13485, FDA Quality System Regulation, ISO 14971)
Working knowledge of and experience in the application of statistical methods
Superior verbal and written communication skills and the ability to effectively communicate with internal and external personnel at all levels of the organization
Graduate degree (i.e. Master, PhD or equivalent degree) in statistics or a related quantitative field with sufficient concentration in statistics, and/or equivalent experience in statistical applications and advanced statistical certification

Principal Quality Engineer Resume Examples & Samples

Qualified to at least HND standard or equivalent experience
Experience / knowledge of Configuration Management within a design / manufacturing environment
Sound knowledge / experience of inspection of Hardware from component level through to sub-assembly and final assembly configuration (COTS / Surface Electronics / Mechanical systems)
Experienced in reviewing / inspecting product against Design and Build Documentation to ensure that products built achieves the established design baseline
Experienced in developing Quality Plans
Knowledge / experience of ESDS (Electrostatic Discharge Sensitive) practices and procedures
Knowledge / experience of Military Standards within a Naval environment, particularly those associated with Product Safety
Knowledge / experience of applying Legislation in products, Low Voltage Directive
Knowledge / experience of Concession Management – Def Stan 05-61, etc
Lead Assessor certified

Senior / Principal Quality Engineer Resume Examples & Samples

Provide support to the Corporate Quality Risk Management program including training materials, risk tool development, facilitation and guidance to all Specialty Care (Biologics) sites in accordance to the Quality Risk Management standard
Provide training to the organization on standardized risk tools such as Failure Mode and Effect Analysis (FMEA), Preliminary Hazards Analysis (PHA), Hazard Analysis and Critical Control Points (HACCP) and other customized risk tools
Lead risk facilitation activities using existing risk practices
Support the development of customized risk tools for various quality system and business applications that support GxP
Interact collaboratively with cross-functional teams in a global, matrix organization. Lead and facilitate teams on a local basis for mid-size projects
Identify and may manage resources required to successfully execute projects
Communicate teams’ progress to stakeholders, management and unit leaders
Leadership Qualities of role
An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes
Bachelor’s degree in a science or engineering discipline and 7+ years of experience in quality/business process improvement experience in the medical device, biotech and/or pharmaceutical industry OR
Experience in a Quality Control laboratory environment greatly preferred
Project Management experience involving proven collaboration, initiation and execution skills leading to the successful completion of business improvements (smaller scale)
Proven interpersonal, facilitation, listening and coaching skills
Good team leadership skills, including the ability to surface and constructively address conflict for productive outcomes
Good verbal and written communication skills, including presentation skills. Able to communicate effectively at all levels of the organization, as well as teach and present new ideas with clarity and simplicity
High level of energy and enthusiasm and ability to energize others
Critical thinking skills to be able to make connections between GxP and business processes
Good understanding and practical use of ICH, ISO and cGMPs regulations
Experience in using various risk tools (FMEA, HACCP and root cause analysis tools)
Up to 10-15% travel as required

Principal Quality Engineer Resume Examples & Samples

Bachelor’s degree in Engineering, Life Sciences, Chemistry, or Physical Sciences OR
Master’s degree in Engineering, Life Sciences, Chemistry or Physical Science
7+ years medical device or combination product experience
2+ years experience in a Quality role
Knowledge of Pharmaceutical regulations including 21 CFR 210/211, ICH guidelines and USP standards
Knowledge of applicable ISO regulations
Understand regulatory requirements for test method and process validations
Experience with Test Method Validation (Measurement Systems Analysis, Gage R&R, correlation and uncertainties) including gage and fixture design
American Society for Quality Certified Quality Engineer and/or Certified Quality Auditor
Experience with data analysis software applications such as Minitab, StatGraphics, SmartProfile or equivalent
Multiple engineering or scientific disciplines (mechanical, materials, chemical, life sciences, etc.) experience is a plus
Experience in program or project leadership, and associated communication, presentation, team facilitation and influence management skills
Demonstrated proficiency with word-processor, spreadsheet, powerpoint and database software

Principal Quality Engineer Resume Examples & Samples

B.S. Degree in Engineering or Science
7+ years of experience in Engineering or Quality OR 5+ years with a Master’s Degree in Engineering or Science
2+ years of experience in Validation areas in Medical Device or Pharma Industry
Experience creating or executing VMPs
Working knowledge of FDA regulations (21 CFR 820, and 11), ISO 13485, and Medtronic quality requirements associated with validation
Knowledge of Software, Process, and /or Test Method validation, specifically in context of Master Validation Plans and associated execution of work
Project management skills (planning and estimating phases, work and task breakdown structures, set milestones, remove barriers to meet milestones)
Previous experience in Front Room as part of an Audit or Inspection

Products Software Principal Quality Engineer Resume Examples & Samples

Demonstrates high level of proficiency in applying established tools and methods to identify and realize new product or process introductions
Partners with senior technical leaders (both internal and external to organization) to develop innovative approaches for realizing technical opportunities
Leads, contributes to assessments of product design
Leads, contributes to the utilization of, and/or develops innovative applications for various risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure mode and effects analysis)
Leads, and/or contributes to, the development of new detection systems by developing optimal methods for conducting software system development, process, and product qualifications/validations
Collaborates with senior technical leaders to develop best practices for system/software development methods
Leads or participates in technical reviews as appropriate
Executes strategic vision or plan by collaborating with other quality leaders to identify required needed software quality engineering skills and competencies
Experience working in a regulated environment (Medical Device, Aerospace, etc). This includes knowledge of, and experience with, applicable standards, GxP requirements and regulations. Required
Development experience with any or all: traditional product software, ATE, customer/product data management, product connectivity, imbedded software – required
Strong knowledge of system development methodologies and software program metrics is required
Experience with system/software Quality Engineering methods, techniques and principles required
Thorough understanding of GxP standards and medical device regulatory and compliance environment including: ISO 13485, 21 CFR Part 320, 21 CFR Part 11, ISO 14971, IEC 62366
Thorough knowledge of and in-depth experience with system development configuration management and change control processes, testing (V&V), issue tracking and defect management are required
Experience with cyber security and data integrity requirements, methods and implementation required
Experience managing projects, and demonstrating project leadership abilities required
Experience with a proven track record of risk identification analysis, appropriate risk mitigation w/in-depth knowledge of product/process Risk Management (FDA & ISO standards) required
Experience with GxP or equivalent data collection required
Demonstrated ability to perform “hands on” troubleshooting and problem solving
Demonstrated project management and project leadership abilities in virtual/cross cultural environment
Working knowledge of failure investigation processes, computer code static analysis methods and tools
Clear and effective communicator (presentation, technical writing, verbal)
Product Development Support
Predictive Analytics / Reliability
Develop and lead others
Results and performance driven
Sense urgency
Strategic thinking
Prudent risk taking
Collaboration and teaming
Self-awareness and adaptability

Principal, Quality Engineer, Audience Studio Resume Examples & Samples

Serve as a principal quality engineer for audience studio data products
Develop and code the testing services that is core to Audience Studio, under the leadership of the Chief Architect
Experience with Jira a must
Self-directed, ability to multi-task, sharp analytical abilities, excellent communication skills, capable of working effectively in a dynamic environment

Principal Quality Engineer Resume Examples & Samples

Implement process control systems and provide technical support for process validations
Perform Complaint analysis investigation as needed
Assist with implementation of EES applications for quality systems
Responsible for following and administering safety

Principal Quality Engineer Resume Examples & Samples

Plan, organize and implement quality programs related to in-process and final product as manufactured at SMP, including product inspections and associated records
Identification and resolution of significant product and software quality issues pertaining to in-process and final materials and associated records
Application of quality control techniques and statistical methods for collection of deficiency and maintenance information to identify failure causes and trends, rate performance and measure effectiveness of quality assurance programs
Bachelor’s Degree in Engineering or a related technical discipline Required
Minimum of Eight years of applicable experience required; manufacturing experience, with previous testing and supervision experience preferred
Knowledge of nuclear regulatory and Westinghouse QMS requirements, preferred/

Principal Quality Engineer Resume Examples & Samples

Provides project direction, coaching, teaching, and mentoring for Quality engineering and technical team personnel
Leads multifunctional teams in completing program directed or continuous improvement activities
Lead in the development and execution of streamlined business systems which effectively identify and resolve quality issues
Perform and/or support analytical test method validations
Design and conduct experiments for process optimization and/or improvement
Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
Lead the investigation, resolution and prevention of product and process non-conformances and out of specifications
Lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)
Design and conduct drug stability evaluations
Sets goals which align to department plans and manages the execution of goals through coaching and mentoring. Maintains a safe and professional work environment
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignment
BS degree in Engineering or Analytical Chemistry or equivalent experience; advanced degree preferred
8+ years’ experience, with at least 4+ years’ experience in drug manufacturing and cGMP
Demonstrated supervisory experience
Engineering experience and demonstrated use of Quality tools/methodologies
Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971, 21 CFR Part 4 and ICH guidelines
Strong 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
Demonstrates technical leadership within the department and outside the department
Prior medical device experience, preferably combination product experience
Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing), including process engineering activities, process validations, defining quality control for batch release activities and driving stability studies
Ability to travel approximately 15-25%, including internationally
Experience working in a broader enterprise/cross division business unit model preferred

Principal Quality Engineer Resume Examples & Samples

Minimum of 10 years experience in Quality or Design Engineering position
Thorough knowledge of Critical to Quality principles with understanding of DFSS, DMAIC, and CPM tools and methods
In-depth knowledge of problem solving and analytical techniques
Expert in statistical analysis and associated tools (e.g. Tableau, Minitab, Statistica)
Ability to establish and maintain effective working relationships with internal team members and external stakeholders
Ability to work with integrity and build trust
Ability to coach and mentor team members and transfer knowledge of CtQ and other Quality tools and techniques
Ability to clearly convey ideas and concepts verbally, in writing, and via presentations
Ability to handle multiple priorities and consistently meet deadlines through effective time management skills

Principal Quality Engineer Resume Examples & Samples

A combination of the following education and experience is required: Bachelor’s Degree with a minimum of 9 years related experience in the medical device, pharmaceutical or biopharmaceutical industry OR a Master’s degree with a minimum of 7 years related experience in medical device, pharmaceutical or biopharmaceutical industry OR a PhD with a minimum of 5 years related experience
A degree in Statistics, Chemistry, Biology, Engineering, or other scientific discipline is highly preferred
Experience with Quality Systems, cGMP, and ICH Requirements is required
A strong background in Engineering is preferred
Experience in a regulated industry required
Strong statistical skills are highly preferred
Project management training or experience highly preferred
Excellent technical writing skills; experienced in writing SOPs, protocols, reports required
Master Black Belt or Black belt certification is preferred
Experience in technology transfer/design transfer preferred
Knowledge of Biotech and/or Pharma Manufacturing preferred
Prior participation in cross functional projects preferred
Knowledge and experience with Bayesian methods preferred
Knowledge of QbD, basic manufacturing processes, LEAN, basic automation/IT/lab systems development (i.e., design of experiments) and test processes preferred
The preferred locations for this position are in: Raritan, NJ; Titusville, NJ; Spring House, PA; Beerse, Belgium; or Schaffhausen, Switzerland, but considerations will also be made for the following sites: Malvern, PA; Horsham, PA; Cork, Ireland; Leiden, Netherlands
This position may also require up to 25% domestic and international travel.Quality (Eng)

Principal Quality Engineer Resume Examples & Samples

6 + years experience with a Bachelor's degree or 4 + years experience with a Masters degree
Bachelor’s degree in engineering preferred
Certified Quality Engineer, Six Sigma Blackbelt, Quality Auditor, Reliability Engineer, or equivalent desired. If Bachelors or Masters Degree is not in engineering an applicable professional certification is required
Experience in medical device or applicable regulated industry
Working knowledge of IEC606-1, UL2601-1, EMC Directive, and other appropriate industry standards
Experience in application of statistical methods to design reliability and process capability
Demonstrated ability to lead project teams to successful completion
Prior experience in a supervisor/manager capacity preferred

Principal Quality Engineer Resume Examples & Samples

Provide site-wide leadership within ALF, to help the site develop and embed risk management as a core business and operational process, helping to implement a set of risk indicators, reports, and identifying key risk exposures and early warning indicators
Act as a Quality representative for formal Risk Assessment teams at ALF as required
Act as a Risk Facilitator for formal Risk Assessments at ALF as required
Ensure that Risk Assessments meet the requirements of Genzyme standards and procedures, are clearly written, and appropriately justified
Ensure that Risk Assessment records are controlled and managed in a compliant manner throughout their life cycle including storage and archiving, and that the record control system meets the requirements of Genzyme procedures
Track, oversee and monitor Risk Assessment records at various points in their life cycle, utilizing compliant tracking tools
Provide guidance to Manufacturing, Quality, Engineering, Facilities and other departments regarding the proper use of the Risk Assessment tools and the risk management process
Helps ensure that key users of the Quality Risk Management system are appropriately trained in regulations and SOPs. Provides mentoring and guidance to users on the Quality Risk Management system, its compliance and regulatory requirements. Monitor performance of the risk facilitators
Monitor the status of open Risk Assessments and mitigations, providing periodic reports and status updates on the overall performance of the Risk Management program to the Site Risk Champion
Propose and help implement modifications to the Risk Management Program to improve compliance, efficiency, and customer satisfaction. Provides timely support to continuous improvement initiatives across the site and the network
Provides support for the Quality Risk Management system during internal and external audits, as necessary
Support the on-time execution of the Annual Risk Management Plan, including influencing system owners to perform their risk reviews in accordance with the Plan
Act as a liaison between the site and Genzyme Global Quality Risk Management for quality risk management issues as assigned
Work with individual system owners to identify and deploy a Facilitator for formal risk assessments
Communicate risks to the appropriate stakeholders including the Site Risk Profile Report author
Support user training, SOP revision and approval, and Risk Management records at the Allston Landing Facility
Participate as Allston a representative of the Risk Management Community of Practice
Interface with project teams to determine the volume of Risk Assessments and Reports anticipated for each project, and provides guidance to the teams on resources needed
5 Years in the Biotechnology industry with 3 years of experience in a quality role in a GMP environment
2 years of experience in Risk Management related to Quality support for ongoing GMP manufacturing operations

Principal Quality Engineer Resume Examples & Samples

Maintaining and continuously improving the QMS (procedures, systems, processes, cost, and yields) related to manufacturing, support, development processes and calibration
Focus on determining roots cause(s) using 8D process for CCAR, ICAR and SCAR in timely manner
Developing and implementing inspection and sampling techniques, quality plans and process control procedures
Establishing and maintaining key parameters for control of process using SPC in manufacturing
Able to use statistical methodology to analyze data and implement action plans for control
Coaching and leading cross-functional teams for KAIZEN improvement projects
Performing internal and external QMS audits with timely closure of findings
Facilitating report and failure analysis of non-conformities with solutions using 8D methodology or DMAIC
Support Program / NPI in reviewing drawings and specs for compliance to customer and government regulations. Conducting or supporting Design FMEA and Process FMEA as well as Control Plans
Familiar with interferometry, spectrophotometry and surface analytical metrology
Interface and liaison with customers, suppliers, and third party auditors
Assisting in supervising QA personnel to ensure on-time delivery of quality products and providing FAI as required
Strong knowledge of Optical Quality requirements
Quality Engineering/Assurance related experience with laser, opto-mechanical and electro-optical components and assemblies
Customer / Supplier interaction experience
Experience with Quality methodologies and tools such as FRACAS, FRB, Root Cause Analysis, FAI, FMEA, DMAIC, DFM, Gage R&R, DFQ, DOE, Six Sigma, etc
Experience with Supplier Source Inspection and Supplier Audits
Ability to use optical inspection equipment such as interferometers, profilometers, etc. a plus
Familiarity with optical manufacturing processes a plus
Knowledge of MS office. Excellent technical writing, verbal communication, and presentation skills
Must be able to work effectively with peers & internal/external personnel, including customers and suppliers, covering a wide range of product development disciplines
Must be highly self-motivated to work diligently to achieve personal and company goals under aggressive program schedules
A Bachelor's Degree in engineering, mathematics, statistics, physics, chemistry, material science, or equivalent
3-5 years of QA Engineering experience working in fast pace ITAR environment supporting commercial and defense customers
Comprehensive understanding of ISO 9001 / AS9100 Quality System Standards
Certified SSGB or SSBB, desired
Proficient on MS Office Suite, SAP, Sharepoint, MiniTab and other data management tools

Principal Quality Engineer Resume Examples & Samples

Managing DP Level and Manifold product quality customer feedback, significant customer quality issues, and customer quality issue communications; potentially working directly with customer quality, management, service, or maintenance personnel
Managing DP Level, Manifold and other Pressure quality issues to closure by forming, leading and participating on temporary technical and business function teams to resolve the issue
Interfacing with supplier quality engineering and various suppliers on product material quality issues and development of processes that improve product quality
Managing the Quality Steering Committee for DP Level and Manifold products. This includes leading bi-weekly meetings, publishing minutes and maintaining the website
Interfacing effectively and maintaining frequent communication with Product group leaders, management, design, product management, and manufacturing for multiple sites for DP Level and Manifold quality
Providing and evaluating product quality metrics
Interfacing with the global Failure Analysis teams by attending the various working sessions, monitoring data and responding to identified quality issues for DP Level and Manifold products
Supporting new product programs by participating in design reviews and product development teams to review quality and reliability criteria
Provide guidance for global manufacturing consistency in design and across multiple manufacturing sites
Participating on and leading quality improvement project teams
Performing other duties as required to support Global Pressure Quality
Action Oriented
Manages Ambiguity
Interpersonal Savvy
Communicates Effectively
Organizational Savvy
Product Knowledge preferred
Ability to convert data into information

Senior Principal Quality Engineer Resume Examples & Samples

Applies state of the art techniques in the area of expertise to develop new or improved products and processes
May lead a large scale program or several small projects with complex features
Independently plans, schedules and leads cross-functional team in detailed phases of the Quality work in a project
Lead audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, ISO and Baxter quality requirements
Maintain a high level of expertise in current regulatory requirements, and serve as a plant resource for compliance to these requirements
Lead in the development of customer awareness and understanding activities for areas of direct responsibility, and where appropriate, assist and support such activities throughout the facility
May supervise one or more engineers or technicians
Must have experience or advanced training and demonstrate proficiency (e.g. computer-aided design, total quality management, statistical methods, problem analysis and resolution, materials science, design of experiments, software development)
Completely proficient in relevant products or process development processes
Successful track record of managing wide-ranging activities within the business unit
Recognized as a technical expert by peers and other personnel within the business unit
Extensive cross-functional team experience, including technical and non-technical work
Ability to organize and present technical and project mgt. overviews without assistance
Strong knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices
B.S. degree in Engineering
8 -10 years’ experience in Quality, Manufacturing, Engineering or related field
Demonstrated success in delivering results on several technical/product/Quality challenges
Experience building product risk files and reliability preferred
Product development experience pertaining to electromechanical devices or disposables preferred

Principal Quality Engineer Resume Examples & Samples

Perform functional, regression testing of applications
Write and execute automated functional test scripts
Create status report detailing progress of all ongoing projects
Attention to detail and a passion for testing
Experience testing Web and Database applications and working knowledge of Unix/Linux, SQL

Principal Quality Engineer Resume Examples & Samples

Perform on-site observations to ensure processes and documentation are correctly executed per requirements and instructions
Identify and resolve issues when practical; report all findings and deviations along with resolution or proposed resolution to higher level PA and Operations management
Perform coaching and training to a diverse array of individuals having different levels of responsibility
Perform in a team environment with all departments at CFFF to ensure oversight efforts are effective and comply with technical specifications
Verify accuracy of procedures, test, records and qualification of processes
Capture data and develop trend analysis to identify probable quality deviation processes and determine oversight intervention needs
Evaluate Operations, Engineering, Administrative and manufacturing plant processes and procedures for correctness and compliance
A Bachelor’s degree in a technical discipline is required
Minimum 5 years of experience required; typically, 8 -10 years preferred
Must have demonstrated project management experience and knowledge of Nuclear Quality Assurance & ISO requirements
Effectively communicate verbally and written to all levels of organization and possess customer facing communication skills
Read and understand engineering drawings, interpret specifications in developing lower level documents
Influence others through coaching, communication, reinforcement and gaining understanding so that ownership is taken by all parties involved
Navigate computer programs such as ENOVIA, CAPAL, etc.… to locate documents required for review during oversight activities
Audit training is preferred
Ability to make decisions based on risk to quality and manufacturing
Planning/scheduling of task based on ability to prioritize task due to assessed risk to quality

Principal Quality Engineer Resume Examples & Samples

Conducts investigation of technical issues, including device evaluation, root cause determination, and action plan implementation
Analyzes complex data sets with advanced statistical methods
Authors complex technical documents for submission to regulatory authorities
Provides effective leadership on assigned projects, and communicates effectively with global team members and suppliers. Includes scheduling and leading project team meetings as required
Works effectively in a cross-functional team environment that includes team members, manufacturing plants, and suppliers in multiple global locations
Works effectively with Operations team members & suppliers to qualify new manufacturing processes & changes to existing processes
Provide Quality Engineering representation on Product Development Teams as needed
Initiate new/revised documentation and track through approval cycles and implementation
Establishes functional & dimensional test methods, equipment, & fixturing as required. Conducts hands-on functional and dimensional evaluation of complex devices and parts. Assures effective transfer of evaluation activities to suppliers and manufacturing plants
Participate and/or lead cross-functional teams to develop risk assessment
Provide positive example and actively promote compliance to division, corporate and industry standards
Prepare and present project updates and technical discussions
Bachelors degree in Engineering or a closely related technical field
A minimum of 8 years experience in the medical device development or closely related industry or Masters Degree plus 6 years
Quality Engineering Certification (ASQ) or equivalent, desired
Lean Six Sigma Black Belt Training or experience
Working knowledge of FDA GMP/GLP, Medical Device Directive, ASTM, AAMI, CEN and ISO
Combination device/pharmaceutical and coating technology experience preferred
Working knowledge of; process validation requirements and application, comparative statistics, engineering cost analysis, internal and supplier audits
Experience supporting product, design & prototyping a plus
Ability to generate engineering proposals
Ability to lead cross functional teams
Understanding of regulatory requirements
Ability to make and present engineering decisions

Principal Quality Engineer Resume Examples & Samples

BS or MS degree in a relevant field or equivalent experience relevant to enterprise storage
8 or more years of quality engineering or storage administration experience on an enterprise storage product
Experience with testing, installation, administration, and management of large-scale storage systems
Strong understanding of enterprise data center architectures including physical and virtual servers, SAN, NAS, and networking
Strong skills in UNIX, preferably with Oracle Linux, Red Hat Enterprise Linux, or Solaris
Excellent troubleshooting skills, especially in high-pressure situations
Experience with both the bug and software development life cycles
Experience with Oracle Database in an enterprise environment (RAC, ASM)
Experience with virtualization (Oracle VM, vmware, or Microsoft Hyper V)
Experience with cloud storage principles and software including Openstack

Principal Quality Engineer Resume Examples & Samples

B.S. in Engineering and 5 - 8 years related experience
Experience in an FDA or other government-regulated operation strongly preferred
Qualified Lead Auditor strongly preferred
Ability to influence management on courses of action with minimal assistance though written and verbal communication

Principal Quality Engineer Resume Examples & Samples

6+ years (with Bachelor's) or 4+ years (with Master's) of related experience
Working knowledge in ISO13485 and ISO14971
Master’s Degree in Engineering or Science (Life Sciences, ME, EE, Industrial technology, etc.)
Experience with structural heart devices and/or catheter based devices
Self-motivated and committed to a small, focused team approach
Strong interpersonal, organizational, and project management skills
Strong oral communicator and technical writing skills
General knowledge of ISO 5840-3
Demonstrated ability to be adaptable
Risk management
Six sigma
Problem solving approaches
Project management methods and tools
Quality System Regulation (QSR)
Good Manufacturing Practices (GMP)
Use of various tools, including microscopes, calipers, and other inspection equipment
May be required to travel frequently to Redwood City, CA during on boarding

Senior Principal Quality Engineer Resume Examples & Samples

Practical understanding of the Design Control process for product development with proficiency in writing and reviewing the design control plans
Proficient with Change Control understanding and execution as a Quality assessor and approver
Must have experience or advanced training and demonstrate proficiency (e.g. total quality management, statistical methods, understanding of biocompatibility, preclinical and clinical studies during product development, problem analysis and resolution, materials science, test method development and validation, design of experiments and life cycle management of product development)
Ability to organize and present technical and project management overviews without assistance
Product development experience with implants and/or biologics preferred

Principal Quality Engineer Resume Examples & Samples

Work with development, product management and other testers to create test cases and automate testing
Work with development to build code and tools to gain additional insight- timing, failure analysis, monitoring
Build sophisticated and maintainable automated test suites to test our universe of products and components

Principal Quality Engineer Resume Examples & Samples

With minimal guidance, schedules and leads a team through the planning and execution of a smaller project or defined piece of a larger project. This includes constructing detailed, accurate project schedules, interfacing with development groups and technical support groups
Devises new approaches to complex problems through adaptations and modifications of standard technical principles
Supervises / mentors / coordinates with junior engineers and/or technicians on assigned work
Ensures compliance with quality systems and regulatory requirements (Change Control, CAPAs, etc.) to assure product quality
Performs and interprets statistical trending analysis to identify trends and emerging issues. Experience with MiniTab is a plus
Performs Change Control and Design Control activities to ensure that all the intended assessments are performed and requirements are met
Utilizes investigational tools to perform Nonconformance and CAPA activities
Ability to engage management and other functions to influence decisions on courses of action with minimal assistance using both written and verbal methods
Effectively operate in and facilitate cross-functional teams with minimal guidance
Must be able to provide solutions that reflect understanding business objectives, cost implications, and engineering challenges
Must have excellent project management skills and the ability to influence others
Capable of problem solving and dealing with ambiguous situations
Occasional travel required (5%-10%)

Principal Quality Engineer Resume Examples & Samples

Responsible for leading cross-functional meetings to identify resources, assess status, and drive timely root cause identification and corrective action development for BSC fielded CRM and EP products and systems. This includes deriving validation or verification plans, implementation strategies, and effectiveness reviews
Works with owners of existing systems to collects and analyze product performance data to support Corrective and Preventive Action activity
BS in engineering or Science field with 9-13 years of relevant work experience OR MS with 7-11 years of relevant work experience
Experience in the Medical Device industry
Strong working knowledge of Microsoft Word, PowerPoint, and Excel
High level of attention to detail and compliance
Ability to effectively support multiple high priority deliverables at once
Creative and innovative thinking
Demonstrated experience managing multiple projects covering diverse (examples: Software, Hardware, Labeling) engineering disciplines
Must be comfortable speaking to groups of individuals. Presentation skills that comfortably and concisely translate field performance to peer and senior management audiences
Knowledgeable of statistical theory and application
Project Management Skills

Principal Quality Engineer Resume Examples & Samples

Assist Quality Manager in maintenance of the facility Quality System specifically develops documentation, testing requirements, sampling plans, qualification and implementation of processes and components in coordination with R & D, Engineering and Production Q.A
Supervises all activities relating to Quality Assessors in the Production Areas. Administers development activities to include performance review, required and special training, disciplinary notices, and quality actions
Supervises all activities relating to Quality Specialists in the Production areas. Administers development activities to include performance review, required and special training, disciplinary notices, and quality actions
Support the Technical QE and Engineering Staff with projects directly related to cost and waste reduction, yield improvements, capacity improvements, cycle-time reductions, Quality System enhancements/excellence, and complex failure investigations
Participate in team-based working groups or task forces
Champion the investigation, determination of root cause, implementation of corrective and preventive action plans, and effectiveness tracking for complex process and/or product failure investigations
Knowledge of Risk Assessment techniques and methods (FMEA) in addressing CAPA, Projects, Validations, etc
Develops, administers, updates, and trains on facility-level procedures to ensure standardization and effectiveness
Assist Quality Manager in maintenance of the facility Quality System, specifically as elements relate to contract review, purchasing, handling, storage, packaging, preservation, delivery and Preventative Maintenance
Responsible for the administration of the section of the quality system handling returned finished goods. This includes the monitoring, tracking and disposition of the returned finished goods applicable to Jacksonville
The incumbent oversees activities related to the Protech Certification Program for the Jacksonville facility
This position requires a bachelor’s degree, preferably with emphasis in electrical or mechanical engineering
Three to five years of experience in the medical device industry, or manufacturing experience are preferred. Previous experience with FDA and notified body audits is helpful
Experience in the application of statistical methods and techniques such as statistical process control, design of experiments and problem-solving techniques are helpful
Knowledge of applicable standards (i.e., ISO 13485:2003, MDD, QSR’s, GMP’s, and CMDR) is also required
Communication, multi-task management, and leadership skills are required for effective performance in this position. This position will serve in a results-driven environment and requires a team-oriented individual. The position facilitates team-based management, developing supportive relationships with all departments, functions and personnel in dealing with product or service quality issues and customer satisfaction
Essential Capabilities
The incumbent is expected to achieve and maintain certification in one or more of the following disciplines: Quality Engineer, Quality Auditor or other ASQ certifications within 3 years of hire

Senior Principal Quality Engineer Resume Examples & Samples

Develops and implements quality programs, including tracking, analyzing, reporting and problem solving
Demonstrates knowledge of reliability, maintainability, and risk management, including key terms and definitions, modeling, systems design, assessment tools and reporting
Applies problem solving and quality improvement tools and techniques, including, preventative and corrective actions and how to overcome barriers to quality improvements
Acquires and analyzes data using appropriate standard quantitative methods to facilitate process analysis and improvements
Applies advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects
Works on or may lead complex projects of large scope
Projects may have significant and long-term impact
Provides solutions which may set precedent
Independently determines method for completion of new projects
Receives guidance on overall project objectives
Acts as a mentor to less experienced colleagues

Principal Quality Engineer Resume Examples & Samples

Act as a systems expert and change agent, facilitating smooth and orderly transition from - Concept into product development into manufacturing quality operations and key supplier modules,
Be responsible for the creation and maintenance of the project DFMEA
Competent is one or more statistically analysis software packages (Minitab, JMP, Reliasoft, etc)
FMEA proficiency required, APiS FMEA software knowledge desirable
Minimum 5 years in an NPI/NPD quality or equivalent role
Critical Thinking, see the big picture and drill down to components of it
Excellent Communications (oral, written, presentation) Skills at different organizational levels
Leadership Skills/Soft Skills
CQE, Six Sigma certification highly desirable

Principal Quality Engineer Asme Control Resume Examples & Samples

The position requires expert knowledge and understanding of 10 CFR Part 50, Appendix B QA Requirements, American Society of Mechanical Engineers (ASME) Standard NQA-1, and ASME III Division 1 / 3 (i.e., Piping Systems, Containments, Components, Supports) and related ASME Documentation Data Packages
Effective verbal and written communication skills are essential as is experience in interacting and developing and maintaining positive relationships with Client personnel and external regulators such as the Nuclear Regulatory Commission and Authorized Nuclear Inspectors
Must possess proficient computer skills (i.e., Excel, Power Point) and the ability to prepare/present formal detailed reports
This Position requires a BS Degree in Mechanical or Electrical Engineering and a minimum of five (5) years of experience in quality assurance, including testing and /or inspection of equivalent manufacturing, construction, and/or installation activities
High school diploma and ten (10) years construction management, two (2) years of this time should be associated with the nuclear field in a supervisory capacity

Principal Quality Engineer Resume Examples & Samples

1) To create test specifications, reviewing existing ones
2) Developing and maintaining test infrastructure and automated tests
3) Capable for reporting, prioritizing and evaluation of software bug
4) Involved in improving quality assurance processes
5) Involved in improving/extending test automation frameworks
6) Able to scope testing effectively, balancing testing requirements
1) BS or MS in Computer Science or equivalent work experience
2) 6+ years of developing / testing Enterprise Applications
3) Excellent understanding of test development
4) Programming Languages: Java , Perl, Python
5) Scripting languages (bash/csh/Gradle), CI (Continuous Integration)
8) Experience testing on Windows, Linux
9) Maintenance focused on Usability, Scalability and Performance
10) Working Knowledge of Mesos/Marathon a plus
12) Prior experience of testing Cloud product is a plus

Senior / Principal Quality Engineer Resume Examples & Samples

Ensure customer quality requirements are clearly understood and communicated to the project team
Lead and facilitate the creation and development of DFMEAs and related documentation to a high standard within the scope of the project and to the required timing
Mentor and train engineers in the use of quality tools, work to propagate and champion best practice across the project and department
Advise colleagues in all matters relating to quality systems
Report and track programme quality status against programme gateway requirements
Ensure that required data on open quality issues is updated on time in project issue-tracking systems
Present the status of documentation and issues in team and project meetings
Organize and lead cross functional problem solving teams through root cause identification, verification and corrective action steps including preventive actions
Utilize resources from appropriate departments to ensure effective, timely cross-functional problem solving
Track quality issues and test failures, working with component owners, suppliers and other stakeholders to facilitate their fast and effective resolution
Support the delivery of parts into production through the APQP process, supporting suppliers in producing PSW and other documentation to achieve PPAP requirements

Principal Quality Engineer Resume Examples & Samples

Bachelors’ degree in computer science or related field; Masters’ degree is preferred
Minimum 9 years experience in software testing and automation within Agile, CI/CD, cloud-based environments
Previous experience testing in public cloud (Azure, AWS, etc.) is highly preferred
Experience with security testing tools is preferred
Leadership experience preferred
Experience with SQL database concepts and queries using SQL
Ability to thrive in a high-energy, high-growth, fast-paced environment

Principal Quality Engineer Resume Examples & Samples

Participate in new product development initiatives by providing quality engineering support to assigned projects
Oversee the Product Development Process and ensure defendable practices and scientific analyses are employed
Provide QA oversight on software, hardware and consumable development process throughout the life-cycle of projects to ensure adherence to procedures as required by QMS
Collaborate with the software development team to ensure that verification and validation activities are complete and robust
Perform document review and approval of software, hardware and consumables engineering documentation (e.g., System Requirements Specifications, Design and Development documentation, Verification and Validation Test plans/ procedures /final reports)
Review and maintain Design History Files and ensure they comply with company procedures and regulatory requirements
Participate in Design Transfer activities
Participate in supplier selection from the design perspective
Participate in product Risk Reviews during product development and post-launch activities
Maintain product Risk Management files
Develop Quality Plans
Assist or lead internal audits and support external audits
Perform review and approval of Engineering Change Request and Engineering Change Orders
Oversee quality procedures for the software, hardware and consumable functions within the Product Development group
Lead process definition and improvement activities and training within the software, hardware and consumable functions
Provide QA oversight on non-product software validation and perform document review and approval of non-product software validation documentation (e.g. Validation Plan, protocols, Validation Reports)
Work with the QMS team to improve awareness, communication, and training on quality procedures and initiatives to support corporate quality goals as a leader in Mass Spectrometry as well as an emerging medical device company
This is an individual contributor level role with a great opportunity to gain hands-on experience in global IVD regulations and medical device QMS
Bachelor's degree in a scientific or engineering discipline (mechanical, electrical, chemical or biological expertise preferable) from four-year college or university and/or training or equivalent combination of education and experience
Post graduate certification or training in Quality Assurance preferable but not required
ASQ CQE certification is preferable but not required
5-10 years QA experience of implementing and maintaining ISO 13485:2003 (21 CFR Part 820 QMS preferable)
Familiarity with IVD regulations in the USA, Canada, Europe
Familiarity with ISO 14971 standard (familiarity with IEC 62304 is an asset)
Familiarity with 21 CFR Part 11 regulation
ISO 13485 or ISO 9001 auditor experience is required
ISO 13485 Lead Auditor certification is preferable but not required
Experience in Risk Management as it relates to Medical Devices products and processes
Exposure to and/or experience with verification and validation of Medical Devices e is required
Experience in QMS documentation writing and review
Experience in the use and application of quality tools, process improvement and info-mapping tools
Systematic problem-solving skills in identifying, prioritizing, communicating, and resolving quality issues
High attention to detail and processes
Strong interpersonal skills and ability to work in a cross-functional team environment, as part of a global company
Strong personal computer skills (e.g. Microsoft Office Suite)

Principal Quality Engineer NPD Heart Valve Therapy Resume Examples & Samples

Responsible for the quality engineering aspects of product design development and design control documentation. Includes process development, risk management, qualification of equipment, and validation of processes, quality planning including inspections, test method development, some level of software validations, and Supplier quality requirements
Advanced understanding of quality systems, statistical techniques, and risk management (considered the ‘go to’ technical person)
Lead and direct the project team applying quality tools and methods that improve efficiencies and effectiveness for design and process development
Responsible for quality systems maintenance and improvement
Trains technical staff in quality systems
Initiate and lead in the investigation of highly complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes based on engineering principles; analyze results, make recommendations and develop reports, based on engineering principles
Drive the development and manage the execution of multiple, highly complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports and lead team members to drive project completion
Lead in the identification and ensure the optimization of highly complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of highly complex equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk
Develop technical content of risk management files
Develop training and documentation materials (e.g., work instructions) to enable the seamless knowledge transfer of project, manufacturing, and business processes
Oversee Quality support tasks; give instruction to engineers/technicians on conducting tests; train engineers/ technicians and provide feedback; and may coordinate engineers/ technician work
Train, coach, and guide lower level employees on highly complex procedures
May be selected as an Independent Reviewer for design review
Lead training, new system procedures, and new method development
Up to 25% travel
Bachelor’s Degree in Engineering and a minimum of 8 years’ experience or Master’s Degree plus 7 years of experience in Engineering
ASQ Certified Quality Engineer (CQE) preferred
Makes decisions in the face of different alternatives and without formulas or guidelines or with guidelines that are not complete and exhaustive, and which allow room for creativity and judgment
Works independently without close supervision
DMAIC and other problem solving and analytical skills. Strong knowledge of statistics and experience with application in a medical device development and manufacturing environment required
Ability to read and interpret drawings
Proven expertise in statistical techniques
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills
Expert knowledge and understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering (e.g., CQE body of knowledge)
Expertise of Six Sigma concepts with the ability to lead projects utilizing these principles
Advanced problem-solving, organizational, analytical and critical thinking skills
Strong leadership skills and ability to influence change and challenge status quo with respect to opportunities for improvement
Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
Ability to manage competing priorities in a fast paced environment
Serves as best practice/quality resource within own discipline or as technical expert on functional or cross-functional teams or projects
Identifies technical gaps and takes action to address them
Represents organization as key technical contact on contracts and projects
Interacts with senior external representatives on significant technical matters often requiring coordination between organizations
Interprets internal or external business issues and recommends solutions/best practices

Principal Quality Engineer Resume Examples & Samples

Supports and ensures the establishment of objective, measurable, discrete, and verifiable customer and product requirements
Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues
Supports in the development and maintenance of Quality Management System procedures
Support audits, CAPA/NCR/SCAR investigations and reports
7-9 years of experience with a Bachelor’s Degree in a technical/engineering discipline; or
4-6 years of experience with a Master’s Degree in a technical/engineering discipline; or
Medical or Pharmaceutical industry experience

Principal Quality Engineer Resume Examples & Samples

Actively represent Design Quality Engineering function on Released Product Engineering (RPE) and Operations Sustaining project teams ensuring product design changes meet Medtronic quality system requirements
Lead or participate in design reviews to evaluate designs and to help identify alternative design solutions
Develops master test plans that encompass design verification, design validation and process validation activities
Leads product risk analysis in conformance with ISO 10497:2012. Leads strategy in in developing design bench and simulated testing. Collaborates with Clinical and Medical Safety in Clinical Risk Benefit and Clinical Evaluation analyses and reporting
12+ years of experience with a Bachelor’s degree. 8+ with a Master’s degree
Self-motivated and committed to a team approach
Subject Matter Expertise / Extensive knowledge of quality tools

Principal Quality Engineer Resume Examples & Samples

Actively represent Design Quality Assurance function as Subject Matter Expert (SME) for Test Method Validation on new product development teams
Creates Test Method Validation strategy and plans for new product development projects
Creation, review, and approval of protocols and reports to ensure that the testing is technically sound and sufficient to meet internal/external requirements and overall project quality objectives
Review and approval of drawings, inspection procedures, and test methods
Mentor less senior Quality Engineers and quality technicians
Lead the investigation of complex technical issues
Hands on participant in early stages of product development including but not limited to physician interaction, prototype testing, and test method development
Identifies and manages risk throughout the development process with the use of FMECA and/or other risk management tools
Prior experience in the Medical Device industry in design and development of Medical Devices
Prior experience with Test Method development and Validation

Senior Principal Quality Engineer Resume Examples & Samples

Act as a “systems” expert and change agent, facilitating smooth and orderly transition from - Concept into product development into manufacturing quality operations and key supplier modules,
Develop with Lead Engineer key/critical characteristics
Coach teams (suppliers as needed) in development of system/sub-module/part quality/reliability deliverables. Conduct Quality Training as appropriate per Diebold Nixdorf Reliability Manual
Assist with the implementation of quality improvements and associated projects using advanced quality tools (for new products/sub-assemblies and parts)
BS degree in Engineering or Natural Sciences
Experience in a systems engineering role desirable
Competent is one or more statistical analysis software packages (Minitab, JMP, Reliasoft, etc)
Minimum of 7 years in a NPI/NPD quality or equivalent role
Product design engineering experience of low to medium volume manufacturing of electro-mechanical products highly desirable
Able to use and instruct others in the use of MSA (GR&R), Cp/Cpk studies, Control Plans, CAPA, etc
Working experience in GDT and design for assembly/manufacturability of complex assemblies highly desirable
Critical thinking, sees the big picture and drill down to components of it
Excellent communications (oral, written, presentation) skills at different organizational levels
Leadership skills & presence/soft skills required
High Energy
Strong MS Office skills required
CQE , Six Sigma certification highly desirable

Principal Quality Engineer Resume Examples & Samples

Represent Quality on strategic cross-functional initiatives/teams. Ensure that Quality Management plans are in place and being followed. Participation method will vary, but must be able to participate at both a steering and doing mode. Represent, coordinate with, and leverage other Quality resources throughout the project
Develop communication plans for critical customer-facing issues, aligning Intelligrated's, problem solving strategy with customer's dissatisfaction points and priorities. Act as Intelligrated's Quality Representative directly to customers on specific major issues
Expand and leverage existing Product Issues Notifications (PIN) and Issue Reporting (IR) processes and utilizing a hands on approach and taking a leadership or team member role on critical / complex issues
Represent Quality on Problem Solving cross-functional teams. Monitor, guide, and escalate as needed to ensure that all problems are addressed using appropriate problem solving methodology
Interface with Global Quality / Manufacturing resources to verify that robust Quality processes are employed consistently throughout the enterprise
Interface with Supplier Quality on key quality issues that impact, or have the potential to impact, Intelligrated's project teams or external customers. Monitor, guide and escalate as needed to ensure that all problems are addressed using appropriate problem solving methodology
Collaborate with Supplier Development and Supplier Quality to maintain awareness of changes to supply chain and potential supplier-related quality issues
Develop and oversee Executive Reports provided to management regarding status of Quality issues
Develop, implement and maintain enterprise-wide training for structured problem solving, using actual Intelligrated case studies and examples
Interface with Supplier Development to make sure that robust supplier evaluation, qualification, and ongoing audit tools are effective at preventing quality issues
Design and implement corporate-wide quality initiatives in concert with the Director / Hardware Quality
May be required to perform other duties as requested, directed or assigned
Ten or more years of direct or related management experience in a complex business model environment
Experience in direct communication to customers (internal and external) regarding quality issues
Demonstrated Quality Leader in engineering and manufacturing- metal fabrication, machine assembly including electrical wiring
Must have experience developing processes and systems as well as supporting development of new products
Bachelor's Degree in Engineering is required. CQE or CQM Quality Certification, Six Sigma Black Belt and Lean Certification is a plus
Flexible to travel up to 10%

Principal Quality Engineer Resume Examples & Samples

BS degree in Engineering or Technical Field or equivalent experience; advanced degree preferred
Prior medical device experience
Experience implementing various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing)
Strong organizational, planning, and follow-up skills and ability to hold others accountable

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How to Make
a Resume

50 Best
Resume Tips

200+ Action
Words to Use

Internship
Resume