Process Quality Engineer Resume Samples
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Process Quality Engineer Resume Samples
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JH
J Haag
Johnathan
Haag
93847 Kassulke Squares
Detroit
MI
+1 (555) 543 2267
93847 Kassulke Squares
Detroit
MI
Phone
p
+1 (555) 543 2267
Experience
Experience
Los Angeles, CA
Process Quality Engineer
Los Angeles, CA
Fritsch-White
Los Angeles, CA
Process Quality Engineer
- Provide audit and inspection preparation assistance to internal clients
- Support the Quality Director in the development of new Quality Management System (QMS) procedures
- Develop, deploy and monitor metrics jointly with Quality leader to drive improvements in the Repair area
- Communicate expectations for continuous improvement and realize incremental improvement through the application of quality tools and techniques
- FTQ, PPM, Off-Line Containment - Assist FF team with using data to drive Continuous Improvement
- Provide trending analysis on quality issues and performance metrics
- Develop and implement the process quality control management systems in operation, including procedures and WI for inspection
San Francisco, CA
Process / Quality Engineer
San Francisco, CA
Armstrong, Schumm and Jacobson
San Francisco, CA
Process / Quality Engineer
- Leading process optimization, root cause analysis and driving scientific and engineering principles into a rapidly changing industrial manufacturing facility
- Implementing product quality improvements by completing root cause analysis leveraging scientific and engineering principles
- Creating, refining, educating, and implementing standard work and process adherence throughout the workforce
- Investigating improvement opportunities and initiating critical manufacturing process improvement projects
- Planning and conducting factory tests to follow through on any of the preceding activities
- Working with production operators, production leaders and other technical support staff in hands-on troubleshooting of technical problems
- Creating and maintaining data collection systems
present
Detroit, MI
Process & Quality Engineer
Detroit, MI
Schoen Inc
present
Detroit, MI
Process & Quality Engineer
present
- Develops working knowledge of all process areas including process flow, operator responsibility, major quality attributes and areas for improvement
- Partner with suppliers’ Quality and Development divisions to improve supply chain quality
- Help oversee and develop manufacturing standards, including machine capacity, quality control, tools and equipment, pathways and cycle times
- Conducts and documents results of process trials to improve productivity and/or quality
- Builds quality systems, conducts lab equipment maintenance and calibration, and creates standard operating procedures (SOP)
- Leads quality focused improvement efforts and projects
- Working knowledge of English
Education
Education
Bachelor’s Degree in Engineering
Bachelor’s Degree in Engineering
Iowa State University
Bachelor’s Degree in Engineering
Skills
Skills
- Basic knowledge of automotive quality systems (APQP, PPAP, Gage R&R, Process Capability)
- Strong technical aptitude (i.e. able to read and comprehend technical documentation, ability to comprehend and execute procedures)
- Knowledge of assorted quality tools and standards (Gage R&R, Capability, PFD, PFMEA, PCP)
- Strong attention to detail
- Quality-Focused, Attentive to Detail and Results-Oriented
- Proficient with Microsoft Office (Word, Excel, PowerPoint, Outlook)
- Quality Core Tools & Problem Solving Methodologies
- Strong grammar, usage, proofreading and editing skills
- Ability to moderate discussions
- BS/BA or equivalent (8 years of experience) with 1 year Process Quality-specific experience
15 Process Quality Engineer resume templates
Read our complete resume writing guides
1
Product & Process Quality Engineer Resume Examples & Samples
- Process and product qualification for the contracted manufacture site
- Quality plan definition, alignment and execution for the contractor manufacture site which includes PFMEA, control plan, CTQ processes, reliability qualification and monitoring plan, Quality reporting, traceability, change control etc
- Working with engineering team on the process setup and optimisation
- Process audit for risk assessment and improvement
- Leading for project phase gate review
- Leading for yield improvement
- Leading for system level reliability assessment plan finalize, execution, risk assessment and reporting as well as the regular reliability monitoring in mass production stage
- EFFA activities: trouble shooting, completely close loop follow up
- Lesson learn activities
- Proactive quality control system setup in contracted manufacture site
- Bachelor degree in technical and engineering
- Technical background, Quality or Process engineering background if preferred
- At least 10 years hands on working experience in electrical industry, 3 years working experience in fast consumer electrical industry
- Expert quality assurance experience in FATP, SMT and Inject Molding
- Expert experience in reliability planning and risk assessment for electrical products& components
- Familiar of DFM(design for manufacture), DFMEA, PFMEA, MSA, PPAP, SPC and sampling plan definition
- Certified Quality Engineer, 6sigma black belt is a plus
- Fluent English skill
- Frequent travel and work under high pressure
2
Process Quality Engineer / Inspector Resume Examples & Samples
- Act as focal point to warehouse and production for incoming and outgoing quality matters
- Approves incoming materials by confirming specifications through visual inspection and measurement; rejecting and returning non-conformance materials
- Approves finished products by confirming specifications and visual inspection; returning products for rework; confirming rework
- Documents inspection results by completing reports and logs; inputting data into quality database
- Initiate corrective and preventive action for non-conformances and report non-conformances via eNCR system
- Arrange calibrations of gauges and fixtures and make sure they are ready to use
- Assist Quality Leader in Data analysis and Presentation (Excel/Powerpoint)
- Support customer FAT events onsite and offsite as needed
- Lead continuous improvement initiatives
- Bachelor’s degree from an accredited university or college (or a high school diploma/GED with at least 3 years of experience in
- Additional experience in the manufacturing industry with a strong focus in quality
- Familiarity with Internal Quality Auditing for ISO 9001:2000
- Prior experience in inspection processes for manufacturing
- Prior experience in Documentation Control
- Strong knowledge of manufacturing processes
3
Process & Quality Engineer Resume Examples & Samples
- Degree in Mechanical Engineering specializing in metal cutting/machining processes
- Manufacturing Engineer / Process Engineer 3 years
- Personnel management, project management
- Autocad, Office, Lean, DMAIC, GD & T, MiniTab
4
Senior Process Quality Engineer Resume Examples & Samples
- Utilize sound Quality engineering background to create, apply, and document quality control plans, process control forms
- Manage process quality control operators to apply kaizen activities to eliminate recorded process quality failures
- Work within a focus organizational structure that supports the focus High 5 metrics
- Responsible for quality initiatives to improved quality performance of the production
- Has a high focus on quality in his daily work on act as a role model in the team
- Coordinates plant quality initiative within hydraulic organizations
- Bachelor of Science in Industrial, Mechanical or Chemical Engineering degree
- Minimum 3 years of experience with fluency in English
- Excellent problem solving, project management and effective communication skills
5
Process Quality Engineer Resume Examples & Samples
- Build productive and collaborative internal/external professional relationships across Design Divisions & GQO functions associated with AO activity
- Communicate effectively with all Customers, Stakeholders and project teams in delivering on AQE responsibilities
- As a key member of NPI project teams, be accountable for implementing quality systems while achieving product performance and quality objectives, project planning and effective execution, as well as communicating program status and escalating issues when appropriate
- Ensure that customer and regulatory requirements are incorporated into product specifications and ensure these requirements have been met before product is released to market
- Ensure Risk Management Principles are generated, applied to the product design, process design and use instructions to minimize risk to patient or user harm. Co-ordinate Risk/benefit justification of the product for its intended use. Ensure all Risk Management outputs comply with ISO14971 for use in Regulatory Submissions
- Provide process validation support, and lead as required, both internally and with vendors. Technically understand the process in question, develop and provide input to process validation protocols, contribute to inspections/tests and analysis of the results
- Has the authority to order the cessation of all activities in relation to design and process validation and new product introduction. In addition,has the authority to order recommencement of these activities provided he/she is satisfied that all issues affecting product safety and efficacy have been addressed
- Lead the development and implementation of incoming inspection, in-process inspection procedures and final inspection plans for associated NPI projects. Minimize inspection costs while maintaining safety, integrity and reliability of the product
- Support vendors during NPI phase in developing quality systems and resolving any quality issues in relation to audits findings, technical specifications, process validation, problem solving, sampling plans development and inspection techniques
- Apply appropriate statistical techniques (Six Sigma, Anova, DOE, SPC, Gauge R&R etc.) to ensure the development of robust, predictive quality systems which are easily transferable and maintainable in a production environment
- Act as a Subject Matter Expert in Design Control for the project team and represent the New Product Introduction team in Audit situations
- Support audit preparation strategy and represent the new product team in Audit situations both third party external (Including FDA, BSI & TGA) and internal Quality Audits
- Lead and plan Design Transfer file activities from initiation to close out as Subject Matter Expert in NPI Design Transfer for the project team
- Provide process development support to ensure process characterization has been completed to facilitate subsequent validation activity
- For new products, ensure the efficient and timely transfer of Quality systems knowledge to Ops Quality and coordinate the training of Quality Engineers and related personnel on new quality systems and equipment as necessary
- Monitor and report new products quality metrics to the company’s leadership team during Post-Market launch for prescribed period
- Perform QMS Review and Approval of all Process changes affecting Stryker IRL sites from a NPI perspective
- Ensure all appropriate documentation is in place prior to production launch
6
Advanced Process Quality Engineer Resume Examples & Samples
- Responsible for the identification of potential failure modes and risks, and the development of quality assurance practices and controls in multiple new product developments and/or manufacturing transfers. Knows and applies the fundamental and some advanced concepts, practices and procedures of the advanced quality specialization
- Support the required stages defined in the product and process design cycle ensuring compliance with the current design control and transfer regulations and policy
- Responsible for the evaluation of process risks and ensures appropriate production and process controls are identified, qualified and implemented throughout the product manufacturing lifecycle (from incoming of materials/components, manufacturing, until product release)
- Excellent interpersonal communication, collaborative team work, and negotiation skills
- Blueprint/engineering schematic reading and interpretation
- Must be able to analyze and correct complex process and/or system issues of a broad scope using independent judgment
- Demonstrated ability to operate small hand tools (e.g. pliers, screwdrivers, hammer, wrenches, etc.), power tools and test/inspection equipment
- Statistical Knowledge: basic concepts (mean, Pp, Ppk, Normality, Hypothesis testing…) and graphical tools (Box-Plot, Pareto, Histogram, etc)
- Basic knowledge on Sterile Packaging technologies and standards
- 3-5 year minimum in Quality Assurance or related functional area such as Design Transfer/Manufacturing Transfer; preferably in medical device, or other regulated industry
- Ability to conduct and document technical investigation
- The following experiences/skill sets are highly desirable
- B.S. in engineering, engineering related discipline or equivalent experience
- ASQ-CQE or CQA desired
7
Process Quality Engineer Resume Examples & Samples
- Provide training to other team members on root cause problem solving techniques
- Has appreciable latitude for independent action or decisions
- Possesses certifications in the quality field such as CQE / Six Sigma Green Belt
- Has the independence and authority to perform required tasks to ensure all provisions of the quality system are met
- Excellent analytical, interpersonal and organizational skills
- B.S. in engineering, engineering management, or related discipline
8
Process Quality Engineer Process Quality & Analysis Resume Examples & Samples
- Become a subject matter expert in supplier processes including receiving, warehousing, clean and screen, refurbishment, out of warranty repair and data process flows
- Develop a best in class quality process audit methodology
- Lead continuous improvement projects to drive quality metrics and reduce total cost to the business
- Develop methodology for performing Gage Repeatability and Reliability studies that maximizes test quality but has minimal production impact
- Drive a data centric mentality in regards to process quality
- Partner with supplier to establish a joint supplier scorecards that identifies and tracks KPIs
- Be self-motivated and have ability to work independently to accomplish goals and tasks
- Perform Root Cause Analysis on process issues that arise and drive Corrective Action Reports
- Experience in a quality control capacity in a warehouse environment
- Experience with Home Networking and Fiber Optics products
- Demonstrated technical expertise in active optical components
- Good understanding of verification test plans, test execution, results collaboration and bug reporting
- Basic understanding of hardware concepts
- Bachelor of Science degree in engineering preferred
- 4+ years of Experience in performing Quality Audits and Process Engineering preferably in a warehouse or manufacturing setting
- ASQ Quality Certifications including CQA, CQE, CQI, CQIA or CQPA (Recommended but not required)
- Six-Sigma or equivalent, specifically knowledge on Lean Process Improvement, 5S, Pareto principle/analysis, RRCA, Fishbone diagram, 5x Why’s, Process Mapping, Value Stream Mapping, and PDCA activities
9
Process / Quality Engineer Resume Examples & Samples
- Leading the plant quality assurance processes
- Ensuring compliance of product attributes to technical specifications and requirements
- Interfacing with sales and customers to resolve any product quality issues
- Implementing product quality improvements, by completing root cause analysis and driving scientific and engineering principles in a fast-paced industrial manufacturing facility
- Using data to analyze and investigate quality issues as well as making at- the-line decisions
- Determining and following through on immediate corrective measures where possible
- Continually expanding product and supplier relationships in an effort to gain sustainable competitive advantage
- Leading group of plant associates to drive quality deeper into the organization
- Implementing new quality systems to enhance the overall performance of plant quality
- Bachelor’s degree in Chemical Engineering or related technical discipline
- 3+ years of technical experience in a manufacturing environment
- Well-developed computer skills including knowledge of Microsoft Office applications and statistical analysis programs such as Minitab
- Excellent communication and personal relation skills to aid interactions with customers and company contacts
- Self-starter with a strong ability to multi-task and juggle multiple responsibilities
- Previous experience with the application of Six Sigma, DMAIC and/or Lean methodologies
- Coatings formulation and application systems experience
- Customer interaction experience including customer visits, customer complaints, claims management, etc
- Experience leading a Quality Management System
10
Process Quality Engineer Resume Examples & Samples
- Identify, prioritize, and implement multiple concurrent process improvement projects, alone or as part of a multifunctional team, to drive customer satisfaction and business productivity
- Support all regions for Nonconformances
- Maintain and audit the quality system established by the QMS
- Support and/or coordinate cross functional team efforts such as Accord or PLM
- Interface with cross functional teams such as Engineering, Order Management, Inventory, Sales, Six Sigma, IT, and Traditional Quality
- Present analysis and recommendations proactively to staff level
- Follow EHS rules and warn others to follow the rules, execute mandatory EHS trainings and immediately report the incidents and near misses as required
- Significant experience in a quality, operations, or engineering role
- Parts or Supply Chain related experience
- Technical or Quality background
- Demonstrated ability to lead projects with minimal supervision
- Ability to comprehend technical documentation
- GB certification (GE Internal Only)
11
Process Quality Engineer Resume Examples & Samples
- Operationalizing and sustaining Fulfilment-5 metrics related to Quality (Web CRT compliance, RCA/NCA cycle, COQ tracking etc)
- Driving a ‘zero exception’ culture with Quality; sustaining Operations compliance to Regulatory & Non Regulatory regulations by engaging the shop floor operators on a daily basis
- Helping the Operations team to operationalize & ensure compliance to QMS procedures and Quality Frameworks
- Leading defect reduction projects and working inclusively with EHS and Engineering to resolve shop floor quality issues promptly
- Championing quality initiatives and COQ reduction projects in the cell
- Conducting assigned audits and developing effective CAPA plans
- Supporting training activities for new employees or when job changes take place in compliance with GE PC training verification process
- Ownership of calibration system for Cell measuring instruments
- Good understanding of workshop practices/processes
- Demonstrated ability to lead change
- Demonstrated EHS and Quality focus
- Six Sigma Green Belt/Black Belt Certified (GE employees only)
- Good working knowledge / Quality control of manufacture/repair processes associated with Wellhead and Pressure control components
12
Process Quality Engineer Resume Examples & Samples
- Lead Product Quality related activities
- Support the Quality Director in the development of new Quality Management System (QMS) procedures
- Develop Product Qualification and Reliability procedures to assure product meets established performance and reliability standards
- Involvement in receiving inspection and MRB activities as related to material issues
- Monitor and investigate product quality and reliability issues and concerns
- Interface with internal and external customers regarding quality and reliability issues
- Drive corrective actions to eliminate recurring process and material related issues
- Work in team environment with manufacturing, design engineering, purchasing and suppliers to improve quality while reducing material scrap and cost
- Communicate expectations for continuous improvement and realize incremental improvement through the application of quality tools and techniques
- Domestic and Global Travel may be required (
- Provide trending analysis on quality issues and performance metrics
- Respond to customer requests for information or product complaints
- Able to lead projects, taking responsibility from project definition through stakeholder acceptance
- Comply with all safety requirements
- Degree in Engineering (Electrical or Mechanical Engineering preferred)
- Minimum 5 years’ experience in monitoring and resolving quality related product issues in a manufacturing/sourcing/engineering environment
- Broad base of knowledge pertaining to optical engineering, and materials a plus
- Ability to troubleshoot complex electrical, optical, and mechanical assemblies to component level
- Ability to effectively present technical information and respond to questions from groups of managers, suppliers, and customers
- Able to coordinate multiple projects effectively
- Strong working knowledge and experience with various computer software including MS Excel (pivot tables, charts), MS PowerPoint, MS Project, ERP and MRP queries
- Strong working knowledge of quality related tools, such as structured problem solving, FMEA’s, SPC, DOE’s and Six Sigma
- Experience with lean manufacturing practices preferred
13
Senior In-process Quality Engineer Resume Examples & Samples
- Write, review and approve exceptions in EQMS
- Lead and participate in Process Improvement teams
- Facilitate and participate in MRB investigations / process
- Oversee and participate in the CAPA process including the writing, review and approval of CAPAs
- Oversee and participate in the Change Control process including the writing, review and approval of Change Controls
- Oversee and participate in the Internal Audit Program for cGMP compliance
- Oversee and participate in the Annual Product Review report process
- Oversee Supplier Quality Program including the review/approval of SCAR responses and auditing / qualification of suppliers
- Evaluate and update existing SOP’s for cGMP compliance and compliance to corporate procedures
- Provide direct support during FDA, other regulatory inspections and customer audits
- Perform trending of Quality Systems including but not limited to: Exceptions, CAPA, Change Control, Annual Product Review, Supplier Quality, and Internal and External Audits
- Incorporate Mallinckrodt Cultural Hallmarks in daily routine
- Excellent communication and leadership skills
- Knowledge of Quality Systems
- Knowledge of cGMPs for Finished Dosage Products
- Understanding of basic statistical principles, expert knowledge of validation principles, techniques, and regulatory expectations
- Ability to build and lead effective teams
- Ability to build relationships with partners
- Ability to understand complex processes
14
Process Quality Engineer Resume Examples & Samples
- PPAP, 8D review and improvement
- Oversees integrity of product quality for assigned area through participation as integral part of manufacturing team
- Provides expert analysis, guidance and support to production in Process Improvement activities, including effective use of Problem-Solving tools / techniques and statistical analysis
- Responsible for New Product Qualification, and verification of changes to current product
- Through the application of APQP, Insures that internal customer needs for Control Systems are met in a timely and functional manner
- Bachelor's Degree in mechanical engineering related is required
- 2~3 years of engineering experience in developing powertrain related automotive products
- Must have an understanding of
- Overall understanding of gasoline and/or diesel engine system
- Components and machining design, and manufacturing requirements
- Good understanding of the TS16949 quality systems
- Preference to applicant with experience in the below
- Good interpersonal savvy
- Good computer skills in Microsoft Office products
15
Process Quality Engineer Resume Examples & Samples
- University or above degree in industrial, mechanical, electrical engineering or similar field
- Above 5 years working experiences in managing the quality
- Person works in auto industry has the priority
- Have training on management of quality
- Good ability in planning, organizing, coordinating, analyzing
- Team work spirits
- Good capacity of strain
- Result-oriented, excellent interpersonal and people management skills
- Willingness and ability to change
- Good English ability in oral and writing
- Familiar with Office software and E-Mail
16
Process Quality Engineer Resume Examples & Samples
- Automotive Industries Customer Specific Requirements
- Customer Change Control Processes
- Customer APQP requirements, Customer’s PPAP requirements
- Quality Core Tools & Problem Solving Methodologies
- Quality Systems Requirements
- Bill of Materials Management
- Customer Systems Access
- Bachelor's degree in an Engineering discipline
- Minimum of 3 - 5 years of work experience preferably in automotive manufacturing environment
- Prefer candidates with ASQ Certification in any of the following: Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE), Certified Quality Auditor (CQA), Six Sigma (SSGB/SSBB)
17
Process Quality Engineer Resume Examples & Samples
- Bachelors’ degree in Mechanical Engineering, Textile Engineering, Quality Engineering or similar technical degree
- Six-sigma training preferred
- Textile knitting experience preferred
- Experience with ISO 9001 and/or TS 16949 is a preference
- Must have strong computer proficiency- Minitab, Excel, Microsoft Office etc
- Ability to write detailed equipment specifications or flow charts that encompass complex plant or line processes
- Certified trained in at least two of the following: Lean Manufacturing, Kaizen or Six Sigma (green or black belt)
18
Senior Process Quality Engineer Resume Examples & Samples
- Manages the activities, development and training of quality and process engineers
- Leads the daily quality activities via use of RCA, CAPA, best practices and quality plan check lists
- Develops a department quality plan that meets the mid and long-term strategic goals
- Provides technical assistance to the manufacturing facility as it industrializes new technology or new processes
19
Process Quality Engineer Resume Examples & Samples
- Documentation - PFMEA, PCP, PFD, OWI's, records, SPC, special characteristics critical to quality (CTQ), Q-Alerts
- RCCA - Root Cause/Corrective Action-champion each event using Fast Response, track from contain to closure, identify owners for CA, engage cross functional team members to assure robust problem elimination
- Gages / Tooling - calibration, maintenance
- TPM - Total Preventive Maintenance; confirm effectiveness, request revision as required to assure robust process, own charts for TPM
- RMA - Returned Material Analysis; engage FF team, provide response in form of analysis, reaction plan, CA
- LPA - Layered Process Audits; participate and champion closure of findings
- QMS - Clear understanding of applicable Quality Management System Procedures
- PPAP / Product Launch - Assist with team members in meeting PPAP submission dates and implementing safe launch practices, including early production containment
- FTQ, PPM, Off-Line Containment - Assist FF team with using data to drive Continuous Improvement
- BS/BA or equivalent (8 years of experience) with 1 year Process Quality-specific experience
- Bachelors of Science degree in an Engineering field preferred
- Strong computer, math, and statistics skills
- Proficient with Microsoft Office (Word, Excel, PowerPoint, Outlook)
- Good presentation skills with PowerPoint experience
- Basic knowledge of automotive quality systems (APQP, PPAP, Gage R&R, Process Capability)
- Knowledge of assorted quality tools and standards (Gage R&R, Capability, PFD, PFMEA, PCP)
- Knowledge of six sigma and project management
- Understanding of Lean manufacturing concepts
- Project management skills (Gantt Charts)
20
Display Process & Quality Engineer Resume Examples & Samples
- Hands-on experience, in-depth technical knowledge, and proven track record in display technologies such as TFT-LCD and AMOLED
- Demonstrated ability to perform display backplane/cell/OLED processes. Capability to execute DOE, SPC, failure analysis and yield improvement
- Experienced in a basic display process technology and operation principles for TFT, LC and OLED
- Periods of travel required - up to 50%
- Desired experience
- Background with TFT LCD and OLED displays, materials, semiconductor process
- Knowledge of TFT, electrical and optical operations in display technology
21
Senior Process Quality Engineer Resume Examples & Samples
- Bachelor’s degree in feed or food industry engineering
- Minimum 15 years previous feed manufacturing or related experience, including production and formulation, and 10+ years feed manufacturing working experience is needed
- Demonstrated ability to work effectively in a team environment. (High)
- Ability to plan and organize multiple priorities, including strong detail orientation. (High)
- Strong problem solving/decision making skill. (High)
- Effective/proven written and verbal communication skill. Good English skills a must. (High)
- Strong fundamental understanding of industry best practices in process safety management
- Proven ability to influence results w/peers, customers (internal and external) and vendors
- Proven ability to manage, lead, motivate and evaluate people
- Strong computer skills, Microsoft Project, PPT, Excel, Outlook and web base applications
22
Display Process & Quality Engineer Resume Examples & Samples
- Hands-on experience, in-depth technical knowledge, and proven track record in display technologies such as TFT-LCD, Sensor and AMOLED
- Experienced in a basic display process technology and operation principles for TFT, LCD, Sensor or OLED
- Excellent written and verbal communication skill
23
Process Quality Engineer Resume Examples & Samples
- Bachelor degree in Industrial, Mechanical or Electrical Engineering
- 4 years of experience as SQA back-office and/or front desk
- Experience and good knowledge of quality methods and processes, e.g. house of quality, FMEA, FTA and Ishikawa
- Working experience in automotive industries and an international environment
- Good knowledge of project management
24
Process Quality Engineer Manufacturing Resume Examples & Samples
- Performs independent technical assessment on product quality performance and post-market product quality analysis
- Frequently interacts with functional peer groups. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects or schedules
- Work on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends
- A Bachelor’s degree in engineering or science or equivalent experience in the medical device industry
- ASQ certified Quality Engineer desired
- Have an 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 understanding of a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements
- Be able to develop and implement quality programs, including tracking, analyzing, reporting, and problem solving
25
Process & Quality Engineer Resume Examples & Samples
- Degree in Engineering required
- Entry level position with experience in an internship in the paper industry preferred
- Basic knowledge of PI (Process Information System)
- JD Edwards knowledge or experience is desired
- Previous experience using a Production Management system preferred
- Good verbal and written communication skills required
- Proficient in Microsoft Word and Excel and an intermediate level
26
Process Quality Engineer Resume Examples & Samples
- Develop, deploy and monitor metrics jointly with Quality leader to drive improvements in the Repair area
- Ensure a systematic means of collecting, analyzing and distributing compiled metrics/information in order to improve quality
- Participate actively to the development and the implementation of the local quality culture plan
- Coordinate all Cell Quality Review meetings
- Ownership for internal NCA/RCA & CAPA plan development & implementation
- Maintain GENSUITE Quality modules in co-ordination with Quality team members
- Work with CI team to drive sustainable process changes
- Overall responsibility for Internal Audit execution, for conformance to quality plans, systems, and requirements as per the Internal Audit Plan
- Providing support to the business supporting new initiatives, as required by the Quality Manager
- Calibration gatekeeper for all Measurement Tools & Equipment
- Support customer meetings when required
27
In-process Quality Engineer Resume Examples & Samples
- Knowledge of ISO 9001:2015
- 5S Tool
- Kaizen
- Basic concept of Geometric Dimensions and Tolerance
- 7 QC Tools
- Basic knowledge about PPAP, MSA
- Basic Knowledge of 7 MUDAs
28
Principal Process Quality Engineer Resume Examples & Samples
- 7+ years of engineering experience in a medical device manufacturing environment
- 5+ years of Process Quality experience
- 4+ years of IQ/OQ/PQ
- Experience in Electronics and Semiconductor manufacturing is highly desired
- Experience with general quality principles, procedures and methodologies
- Experience with Corrective and Preventative Action planning and implementation
- Six Sigma or Lean Sigma belt certification
29
Process / Quality Engineer Resume Examples & Samples
- Four year Degree in Mechanical, Industrial, or Chemical Engineering required
- 3-5 years experience in a Quality Engineer or Process Engineer role in a manufacturing environment required
- Strong skills in Root cause analysis, waste reduction, and efficiency improvement desired
- Certified Quality Engineering certificate preferred. Six Sigma certification a plus
- Microsoft Office application proficiency including capabilities in Access programming. Use of Minitab in data analysis
- Prior experience with film coatings, chemicals, lamination, injection molding or thermoforming is a plus
- Strong demonstration of presentation skills
- Familiarity with ASQ Body of Knowledge
- Able to be on call (24/7) as needed
- Able to travel approximately 25% of the time
30
Process Quality Engineer Resume Examples & Samples
- Bachelor's degree or higher from an accredited university
- Minimum of three (3) combined years of quality assurance and/or manufacturing experience
- Knowledge of ISO9001-2015
- Demonstrated ability to lead teams and lead continuous improvement
- Ability to multitask, prioritize and drive projects to completion
- Previous experience using Lean Six Sigma methodologies
31
Process Quality Engineer Resume Examples & Samples
- Domestic and Global Travel may be required (< 10%)
- Degree in Mechanical Engineering
- Broad base of knowledge pertaining to optical engineering, and mechanical assemblies
32
Senior Process Quality Engineer Resume Examples & Samples
- Engineering Educational background
- Over 10 years Class II/III Medical Devices Experience particularly capital equipment and portablesFamiliar with device V&V and other manufacturing process qualifications
- BlackBelt LSS certification from reputable company is plus
- Product Quality and PLCM project improvement
- Supplier Quality and Scorecard development
- Familiar with CAPA and Audit
- Analyzing Information , Reporting Research Results, Technical Understanding, Promoting Process Improvement, Developing Standards, Managing Processes, Manufacturing Methods and Procedures, Supports NPI, Quality Engineering, Operations Research
33
Manufacturing Process Quality Engineer Resume Examples & Samples
- Ability to function well in a fast-paced, ambiguous work environment
- Ability to manage multiple projects and tasks simultaneously
- Ability to lead a team to execute and deliver business results
- Ability to effectively influence, negotiate, and communicate with internal and external business partners, contractors and vendors
- Ability to dive deep into financials and cost/budget analysis
- Ability and willing to perform technical aspects of the position
- Drive continuous improvements through the use of lean principles, utilizing the IR Business Operating Standards for Operational Excellence
- Work closely with Design and Sustaining Engineering to develop Value Engineering opportunities to reduce material cost and drive labor productivity improvements
- Work collaboratively with Packaging Engineering on packaging designs and materials to facilitate lineside presentation and flow of materials
- Lead Make vs. Buy analysis for purchased kits and subassemblies, evaluating for insourcing opportunities based on economies of scale and leverage
- Develop error proofing for subassembly and kitting operations, leveraging MES and other technologies an appropriate
- Work in concert with ISC Materials team to record and maintain dimension and weight data of components and subassemblies in support of PFEP
- Develop and implement ideas for Productivity, Rapid Improvement and Kaizen projects
- Writes new process instructions and standards as necessary and develops training materials and trains users in all tools, measurements and procedures required
- BS or MS degree in Engineering or related technical field
- 10 plus years of experience in manufacturing engineering and quality management
- Experience in engineering systems to include CAD, PLM and MES systems. ProEngineer and Windchill PLM experience and knowledge preferred
- Knowledge and understanding of advanced quality planning tools, including FMEAs and Control plans, to meet Quality requirements and targets
- Ability to participate in design reviews and assist during validation and qualification, to include safety and ergonomics
- Experience with lean principles and techniques to include Visual Management, Kaizen, Value Stream Mapping, Cycle Time Reduction and Process Balancing, Yokoten, 5S, Set Up Reduction (SMED), and Kanban
- Ability to provide feedback to suppliers and trading partners regarding quality issues and continuous improvement opportunities
- Experience in manufacturing and warehouse environments
- Knowledge of Materials Management and Logistics practices
- Working knowledge of ERP systems
- Exceptional analytical and detail problem solving skills
- Travel should be less than 10%
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Process / Quality Engineer Resume Examples & Samples
- Supporting plant safety with active participation in safety audits and risk assessments
- Leading process optimization, root cause analysis and driving scientific and engineering principles into a rapidly changing industrial manufacturing facility
- Planning and conducting factory tests to follow through on any of the preceding activities
- Writing the test plans, observing the test runs, directing experimental process adjustments during tests, evaluating test results, writing reports, and recommending and initiating subsequent action to be taken
- Working with production operators, production leaders and other technical support staff in hands-on troubleshooting of technical problems
- Providing technical expertise and leadership in applying process improvement tools such as Lean Manufacturing principles, Six Sigma, design of experiments and statistical process control and use these tools to identify and improve plant performance
- Investigating improvement opportunities and initiating critical manufacturing process improvement projects
- Continually coaching production operators in the use of process control techniques
- Creating, refining, educating, and implementing standard work and process adherence throughout the workforce
- Creating, maintaining, and ensuring compliance of product attributes, technical specifications and requirements
- Working with sales and customers to resolve any product quality issues
- Implementing product quality improvements by completing root cause analysis leveraging scientific and engineering principles
- Creating and maintaining data collection systems
- 1+ years of technical experience in a manufacturing environment
- Ability to work in an industrial environment (i.e. Ability to wear required PPE, work in a dusty, hot, non-climate controlled environment; with stairs, frequent walking, standing and occasional lifting of material)
- Ability to work off shift hours in support of plant initiatives
- 3+ years technical experience in a manufacturing environment
- Customer interaction experience including customer visits, customer complaints, claims
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Process Quality Engineer Resume Examples & Samples
- Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or Related Field
- English level required B2+: 70-79%
- 2+ years of experience in similar positions
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Process Quality Engineer Resume Examples & Samples
- Develop, deploy and monitor metrics jointly with SC quality leader to drive manufacturing improvements in the area
- Ownership for deployment of preventive methods and implementation of the resulting improvement actions
- Lead , develop, coach factory staff on key compencies acc. to the needs
- Ownership for implementation of improvement actions resulting from quality plans and customer feedback through continuous improvement
- Support Q-framework, QMS and ISO audits as required
- Support regulatory compliance and optimization of quality systems procedures
- Support RCA's & CAPA plans for external defects
- Engineering bachelors Degree or suitable practical experience
- Proven expertise in customer resolution & preventive tools, ISO knowledge
- Inclusive leadership & communication skills
- Knowledge of repairs
- Demonstrated ability to self-direct within defined responsibilities
- Knowledge of Lean and/or alternative continuous improvement methods
- Must be a team player willing to sacrifice individual goals when needed
- Experience dealing with customers
- Knowledge of RCA and CAPA tools
- Foreign language skills: French, English and any other additional languages is a plus
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Process Quality Engineer Resume Examples & Samples
- Develop and implement manufacture process quality control plan including procedure and WI for inspection. Ensures the control plan is applied
- Evaluates the quality level of the finished product and the manufacturing process
- Non-conforming quality cost reduction, by NC problem analysis and improvement actions leading
- Drive quality continuous improvement Performs analysis of quality problems in manufacture process & customer complaint, push improvement in the plant
- 3+ year experience in process quality and customer quality field
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Senior Process Quality Engineer Resume Examples & Samples
- Position requires a Bachelor’s of Science Degree in Engineering or equivalent experience, and minimum 7 years direct Quality Engineering experience
- Lean / Six Sigma experience, Black Belt is a plus
- Working knowledge of Excel, Word, Access, quality software, and statistical methods (SPC, DOE, Gauge R&R etc.) and risk management techniques (dFMEA/pFMEA)
- Work attitude that exhibits drive, creativity, collaboration, assertiveness, good judgment, decision making and ambition
- Excellent interpersonal skills: ability to build and maintain relationships with internal and external customers; highly functioning team leader and team member in a multi-skilled, dynamic business environment
- Leadership Skills: Proven ability to influence others and lead significant change
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Process Quality Engineer Resume Examples & Samples
- Development and operation of quality control systems,
- Application and analysis of testing and inspection procedures,
- The ability to use metrology and statistical methods to diagnose and correct improper quality control practices,
- An understanding of human factors and motivation,
- Quality cost concepts and techniques,
- The knowledge and ability to develop and administer management information systems
- Job Responsibilities
- Plans the effort to cause quality in processes, products and human resources
- Collects, analyzes and speaks with data
- Performs Measurement System Analyses
- Participates in and validates engineering changes, FMEAs, etc
- Leads continuous improvement projects
- Performs PPAPs, Capability Studies, Gage Studies, Statistics Based Manufacturing
- Creates boundary sample boards and samples and control plans
- Evaluates, monitors, and reports on supplier performance
- Manages calibration systems
- Participates in quality causing activities, Root Cause Analyses, Continuous Improvement Projects, customer and internal quality meetings
- Education and Training Requirements
- Certified Quality Engineer (CQE) *
- Certified Quality Auditor (CQA)*
- Certified Six Sigma Blackbelt *
- Certified Lean Practitioner*
- Core Tools User (APQP, MSA, FMEA, PPAP, SPC, 8D, CP)*
- Four- year degree REQUIRED, plus a minimum of 5 years’ experience actively using Quality Management System tools
- JDE User*
- Minitab User*
- Design of Experiments (DOE) training and experience
- preferred, but not required
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Process Quality Engineer Resume Examples & Samples
- 50% travel in Asia, to include China, Singapore, Japan, Taiwan and Korea
- You will be focuses at 30% SME subject matter expert in assembly setup, fixture/jig design and discussion
- Conduct - PFMEA, SPC(statistical process control), DOE, PCP and Capacity study in NPI stage, with a clear goal of Component Qualification Planning (CQP)
- You will define – PCP(precision colour printing), CTQ (special characteristics critical to quality) and CAPA investigation in NPI stage
- You are an authority on RCCA - Root Cause/Corrective Action-champion each event using Fast Response, track from contain to closure, identify owners for CA, engage cross functional team members to assure robust problem elimination
- We need expertise with gages / testing - calibration, correlation over process establishment with GR&R tools, and LPA - Layered Process Audits; participate and champion closure of findings
- You have a clear understanding of applicable Quality Management System Procedures, along with Continuous improvement (CI) on the subjects behind RFQ target with cost-effective approach
- You know how to handle Transfer – Transfer established processes and tools to SQE in early MP stage
- We would like to see a BS/BA or equivalent (8 years of experience) with 1 year Process Quality-specific experience. Bachelors of Science degree in an Engineering field is strongly preferred
- Strong computer, math, and statistics skills with a high-level of proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook)
- Good verbal and written communication skills in both English and Chinese and great at working with multi-cultural teams
- You have a Six Sigma Green/Black Belt Certified, LEAN, and a have a Process Quality Engineering background,
- Knowledgeable in the DOE, PCP, etc., Good design and statistical knowledge, CQP, Capability to train not just Engineers but suppliers
- You have solid working knowledge of and the use of CAD (Solidworks or Pro/E), manufacturing software, engineering drawings, gauging and calibration, GD&T and CMM
- Did we mention is it would be fantastic if you had 3D CAD experience
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Process Quality Engineer Resume Examples & Samples
- Assist internal clients with interpretation of applicable standards and regulations as it pertains to their work responsibilities and software solutions
- Work in conjunction with internal clients to recommend a set of corrective actions or process changes to identify and manage risk
- Assist internal client groups with data gathering, problem and risk analysis, and evaluation of potential regulatory risk
- Document and coordinate internal regulatory processes
- Assist in the reviews of Complaints
- Provide audit and inspection preparation assistance to internal clients
- Identify and provide educational opportunities to relay information to internal clients
- Assist internal clients with development and tracking of quality goals
- Assist with internal audits (e.g., provide interview support, participate in follow up meetings, and review audit reports)
- Assist with compilation and preparation of materials for regulatory submissions
- Participate in writing and maintaining documents that support regulatory tasks and the Cerner Quality System
- Participate in the preparation of monthly, quarterly, and bi-annual management reporting
- Identify areas for improvement and facilitate the improvement process
- 2 plus years of experience working in a software organization
- Ability to clearly present information, both verbally and in writing
- Ability to interact with internal clients and co-workers in a productive and collaborative manner
- Ability to develop and maintain constructive and cooperative working relationships with others
- Ability to analyze information and evaluate results to select best method to solve issue
- Ability to analyze and apply information
- Ability to moderate discussions
- Understanding of US & Global medical device regulations and/or ISO quality management standards
42
Process / Quality Engineer Resume Examples & Samples
- Lead and Support shop with special processes such as: Weld, Heat Treatment, NDT, Plasma, Cleanline, and others, to achieve and maintain regulatory requirements
- Modify/Mentor/Train shop floor personnel on process standards and improved techniques
- Identify, develop, and implement process controls to meet customer/specification requirements and improve operating performance
- Prepare technical packages for Internal & Customer review: First Article, PPAP, PFMEA, and VSE, MRB concessions, etc
- Investigate and provide effective relentless Root Cause Analysis along with Corrective and Preventive Actions for process and product non-conformances
- Participate in cross-functional teams on process control, improvement, and optimization projects; participate in other BES activities (i.e. Kaizen, Baseline, Production, and Preparation Process (3P)
- Engineering change review and update of improvements in routers standards
- Address and Maintain operator written examinations requirements
- Three years of related experience in manufacturing environment, preferably in an overhaul and repair operations
- Computer literacy with proficiency in Microsoft Word, Excel, and PowerPoint; expertise in AutoCAD required
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Process & Quality Engineer Resume Examples & Samples
- Help oversee and develop manufacturing standards, including machine capacity, quality control, tools and equipment, pathways and cycle times
- Help meet Quality objectives
- Partner with suppliers’ Quality and Development divisions to improve supply chain quality
- Study and implement corrective manufacturing measures following receipt of customer non-compliance reports
- Participate in planning and help determine project stop and start schedules, capital spending and budgeting
- Take steps to optimize site planning
- Share knowledge and understanding of industrialization processes by training and guiding others
- M.S. in Engineering
- Experience in production site Methods, Quality and Industrialization desired
- Working knowledge of English
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Process Quality Engineer Resume Examples & Samples
- The Quality Engineer II should excel in an environment that embraces change, risk, and flexibility
- You should be willing to make a visible contribution and therefore, be able to work independently
- The Quality Engineer II will support day-to-day manufacturing operations in the areas of non-conformance review and evaluation, process verification and validation, process risk assessments, inspection methodology and acceptance criteria for Inspection sample plans, root cause investigations, and collaborating on corrective action
- You will support cross-functional teams working on cost improvement projects, and may support Manufacturing Engineering in the creation of travelers, routes, bills of material, print changes, and specifications for in-house manufacturing
- The Quality Engineer II will provide leadership in the understanding of the QSR and ISO 13485 regulations both within Quality and to other disciplines and help represent Quality during Third Party audits
- You will communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Manufacturing, and Marketing. He or she will be responsible for implementing Quality System improvements to meet compliance and overall business goals as denoted by your supervisor or our Chief Compliance Officer
- A minimum of 2 + years of experience are required
- Experience in process quality and validation is an asset
- Experience in a highly regulated industry is an asset
- Experience in the Medical Device industry is an asset
- Experience with FDA and ISO regulations is an asset; FDA CFR Part 820 and ISO13485 knowledge preferred
- Good communication, partnership, and decision-making skills are required
- Experience with root cause analysis tools is required. Geometric dimensioning and tolerancing experience is preferred. Six Sigma, Lean, or ASQ Certification and trainings are an asset
- A minimum of a Bachelor's degree is required. Focus degree in an Engineering, Life Science, or related discipline is preferred
- This position will be based in Palm Beach Gardens FL, and require up to 10% travel
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Process Quality Engineer Resume Examples & Samples
- QA review/leadership for Equipment Controls processes, including calibration and preventive maintenance (PM)
- Working cross-functionally to ensure proper handling, storage, maintenance and calibration of equipment per Equipment Control procedures
- QA review/leadership for ESD and Environmental Controls in production, including record reviews
- Investigation of impact to product, including risk assessments, due to out of tolerance (OOT) equipment and environmental conditions
- QA review/leadership for CAPA investigation activities
- On-time completion of individual training for procedures relating to job function
- Support of Regulatory agency audits and inspections in areas of responsibility
- QA review/leadership relating to accurate recordkeeping (GDPs)
- Interface with cross-functional teams to ensure compliance and timely product releases
- Bachelor’s degree in QA, Engineering, or related field OR equivalent (i.e., high school diploma/GED plus 4 years working experience, within QA engineering in the medical device industry)
- 3+ years of experience with Equipment Control processes
- 3+ years of experience with ESD/Environmental Controls
- Strong technical aptitude (i.e. able to read and comprehend technical documentation, ability to comprehend and execute procedures)
- Ability to communicate effectively (both written and oral) using English (or local language)
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Process Quality Engineer Resume Examples & Samples
- Liaison with customer base for source inspection activities. Work with Sales, Service and Program Management to ensure conversion of customer requirements
- Plan perform, and record completion of test method audits in accordance with MIL-STD-883 and MIL-PRF-38534
- Initiates Corrective and Preventative Action, reviews proposed solutions for effectiveness and ensures timely closure
- Development and maintenance of technical flows and standard operating procedures to support inspection, verification, and validation of Hybrid and PWB products
- Quality planning activities include ensuring accurate inspection criteria definition as needed to satisfy contract, engineering drawing and specification requirements
- Actively leads material defect investigation, analysis, and disposition tasks
- Reports on process performance and status through meetings, tasks, and actions
- Supports all functional areas to enhance management system methodology while ensuring standardization of process definition within documented processes
- Involved in relevant metrics development and implementation
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Process Quality Engineer Resume Examples & Samples
- Responsible 8D on time to customer,
- Attend daily meetings
- Implement POKA YOKE for corrective actions
- Manage contention actions as a principal actions
- Evaluate Rankings for PFMEA focus on the occurrence and detection to avoid re incidence on the failure modes
- Apply core tools and analysis to take professional decisions
- Requirements
- Bilingual English - Spanish
- Core Tools (MSA, SPC, PFMEA, Control Plan)
- Experience on customer issues
- Solving problems
- 8D skills
- Quality tools
- Statistic analysis
- Experience in automotive industry
- ISO TS 16949
- Risk and impact analysis
- Valid US VISA & Mexican Passport
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Senior Process Quality Engineer Resume Examples & Samples
- Your experience in a regulated environment within an R&D or manufacturing will allow for quick advancement
- You should have familiarity with ISO 13485, QSR, GDP, GMP desirable
- Lean Six Sigma training is a distinct advantage for you
- Working knowledge of Process Validation and Computer System validation
- Analytical skills, process improvement orientation, and the ability to handle multiple tasks in a dynamic, productive environment are ideal
- Ability to read and interpret complex engineering drawings and have a deep understanding of geometrical dimensioning and tolerance
- Ability to lead several projects through the use of excellent analytical skills in planning, organising, and implementing multiple concurrent tasks
- Excellent communication and relationship management skills that allow you to express ideas and collaborate effectively with multidisciplinary teams
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Process Quality Engineer Resume Examples & Samples
- Develop and implement the process quality control management systems in operation, including procedures and WI for inspection
- Support New Product Introduction quality planning (APQP) and PPAP
- Coordinate for specific products across quality functions
- Drive for process continual improvement activities
- Perform diagnosis, trouble shooting, analysis and RCCA using quality tools and statistical techniques
- Responsible for cost of poor quality by promoting quality cost concepts and awareness among the VS
- Provide product, process and quality related tool trainings to VS members
- Promote product reliability and safety among the VS
- Enhance customer satisfaction by delivering zero defect products to customer
- Support ISO/TS internal/external audits and customer related audits
- 6-8 yrs in process quality from tier-1 Auto manufacturing
