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Top 50 Principal Quality Engineer Skills

Below we've compiled a list of the most important skills for a Principal Quality Engineer. We ranked the top skills based on the percentage of Principal Quality Engineer resumes they appeared on. For example, 13.7% of Principal Quality Engineer resumes contained Product Quality as a skill. Let's find out what skills a Principal Quality Engineer actually needs in order to be successful in the workplace.

These are the most important skills for a Principal Quality Engineer:

1. Product Quality

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high Demand
Here's how Product Quality is used in Principal Quality Engineer jobs:
  • Reviewed product quality reports with senior management and sales/marketing departments.
  • Coordinated with suppliers to resolve product quality issues
  • Interfaced with operations personnel, customers, management, production control, auditors and suppliers on all issues concerning product quality.
  • Led Tiger teams to address critical customer issues and solve complex product quality issues and bring resolution to restore customer satisfaction.
  • Consulted with upper management regarding Quality improvements that would result in cost savings and improvement of product quality by 30%.
  • Worked with global vendors and manufacturing sites to implement corrective actions to improve product quality and processes.
  • Lead cross-functional teams to execute plans/schedules that support goals & Product Quality Plan (PQP).
  • Established metrics and procedures for maintaining high standards of product quality, reliability and safety.
  • Developed Risk Assessments and Health Hazard Evaluations on process/design changes and product quality issues.
  • Facilitate Advanced Product Quality Planning (APQP) techniques with suppliers.
  • Managed Product Quality Engineering throughout the product life cycle.
  • Led improvements to enhance product quality.
  • Served as the Product Quality Manager for numerous mailing systems produced by Pitney Bowes.

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2 Product Quality Jobs

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2. Ensure Compliance

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high Demand
Here's how Ensure Compliance is used in Principal Quality Engineer jobs:
  • Conducted equipment, process and material validations to ensure compliance with facility procedures, regulatory requirements and industry standards.
  • Work closely with operators to ensure compliance to specifications.
  • Audit supplier procedures and operations to ensure compliance with both ISO 9001 and military requirements.
  • Work to ensure compliance with corporate quality systems requirements.
  • Perform audits of World Wide Allergan suppliers to ensure compliance with local and international regulatory requirements and Allergan Standards.

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2 Ensure Compliance Jobs

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3. Audit Procedures

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high Demand

4. Supplier Quality

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high Demand
Here's how Supplier Quality is used in Principal Quality Engineer jobs:
  • Developed relationships with suppliers to perform supplier quality engagements, proactive assessments, and various qualification and process verification audits.
  • Succeeded in critical parameter supplier quality improvements and corrective actions using disciplined approach.
  • Used Continuous Improvement tools to eliminate chronic Supplier quality problems.
  • Investigate supplier quality issues concerning products and/or processes.
  • Led team in developing initial in-house and supplier quality metrics tracking database.
  • Resulted in reduced supplier risk and improved supplier quality.
  • Chair of Supplier Quality Team.
  • Monitor PCB and PCBA supplier Quality with C/A on issues.

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17 Supplier Quality Jobs

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5. ISO

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high Demand
Here's how ISO is used in Principal Quality Engineer jobs:
  • Performed gap assessments and developed risk mitigation strategies for new and updated Global Quality & Regulatory Standards including ISO.
  • Participate on procurement-focused Strategic Sourcing Teams as a Quality Assurance liaison.
  • Developed and implemented the Quality Management System for ISO9001 Certification.
  • Isolated and corrected a previously incapable process that that led to $2,4M Yr. in revenue for a delivery catheter.
  • Conducted internal audits in support of maintaining ISO, BSI and UL certifications and external audits for supplier certifications.
  • Conducted a Field Assessment for a novel device to support product launch and ISO 13485 requirements.
  • Managed QA Supervisor and staff of 11 QA Technicians across three product manufacturing lines and warehouse.
  • Trained to ISO 14971:2000 standard for Risk Management to apply risk assessment to the QMS.
  • Maintained Quality Management System in accordance with ISO 13485, 21 CFR part 820.
  • Audit Team Lead and Lead Auditor for all Division ISO 9002 functions and activities.
  • Lead risk management activities per ISO 14971 throughout product life cycle.
  • Conducted Supplier Audits based on Customer, or ISO9000 requirements.
  • Initiated corrective actions when necessary per ISO 9001/AS9100 processes.
  • Coordiated ISO9001:2008 and Automotive ISO/TS16949 internal and external audits maintaining compliance and business critical certifications.
  • Acted as Lead Internal Auditor, Audit Program Administrator, and Corrective Action Administrator for the AS9100 and ISO14001 systems.
  • Performed the company startup establishing and maintaining the quality system in accordance with QSR and ISO requirements.
  • Managed suppliers and performed supplier audits to comply with ISO 9001 or other applicable QMS'.
  • Managed and maintained the Full Quality and ISO 13485:2003 Certificates across all Cordis sites.
  • Led team to obtain ISO 60601 certification for class 3 electronic device.
  • Provided in-house as well as on-site supplier ISO 9001 auditing.

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26 ISO Jobs

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6. Capa

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Here's how Capa is used in Principal Quality Engineer jobs:
  • Developed a Process Capability Methodology for purchase parts.
  • Participate in corrective and preventive actions (CAPA) related activities, including CAPA ownership if appropriate.
  • Created a team to update the CAPA system from manual to an electronic system using Fast track.
  • Overhauled the Preventive Maintenance System under a CAPA resulting in a 98% reduction in paperwork.
  • Led and executed CAPA and NC projects including issue management, problem solving, and remediation.
  • Identified systemic issues and recommended CAPA's that have since been adopted.
  • Lead and participated in efforts to improve the CAPA System process.
  • Published performance test results and capacity planning guides.
  • Document all CAPA activities using TRACKWISE Software.
  • Established effectiveness review plans for CAPA/PA.
  • Team member of the CAPA Review Board.
  • Led Out of Specification investigations coached quality investigations at Puerto Rico manufacturing site and participated in CAPA activities.
  • Lead multi-disciplinary team CAPA/PA investigations.
  • Used deviation process to negotiate changes in technical specifications through CAPAs leading to re-validation of key AB liquid soap making process.
  • Relocated two major OEM product lines to a new facility and qualified additional capacity with zero backorder and zero complaints.
  • Work closely with Production and Engineering to investigate non-conformities, resolve audit observations (external) and CAPA investigations.
  • Negotiated the end of R&D quarantine shipments using CAPAs for major deviation.
  • Maintained metrology, calibration, material spoilage, Deviation and CAPA documentation.
  • Batch record review and improvement Consent decree remediation Trackwise/CAPA remediation
  • Manage Quality Engineering plan for multiple QEs for CAPAs, Complaints and NCRs.

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2 Capa Jobs

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7. Assurance

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high Demand
Here's how Assurance is used in Principal Quality Engineer jobs:
  • Designed and implemented a web-based technical review system for the quality assurance of software design specifications and functional specifications used company-wide.
  • Supported continuous improvement activities through a newly developed and implemented electronic quality assurance data sharing system.
  • Managed quality assurance receiving, final product release and quality engineering group.
  • Design Assurance lead on three new generation biopsy devices launched within the year, which met the CE Device marking requirements.
  • Maintained and improved the company s QMS securing continuous compliance with the U.S. and international quality assurance and regulatory standards.
  • Authored Quality Assurance Program Plans to communicate how contract specific quality requirements would be met.
  • Report progress to SGSS project Chief Safety and Mission Assurance Officer at GSFC.
  • Lead engineer responsible for implementing quality assurance standards for all new products.
  • Work as Lead Auditor in Nuclear Oversight (Quality Assurance) department.
  • Establish and support Quality Assurance Plan and FAI's for programs.
  • Design assurance R&QE support for Auto Plasma business unit.
  • Supervised three junior engineers in the Design Assurance Quality Engineering group.
  • Apply Product Assurance Provision (PAP) Codes to vendor items.
  • Create DO-178C Software Quality Assurance Plan (SQAP).
  • Communicated changes in quality assurance policies and systems as well as developing and conducting education and training programs.
  • Created FAI plans & QAPPs (Quality Assurance Program Plans) for my assigned programs.
  • Provided design quality assurance, incorporating risk/hazard analysis, quality systems compliance, and design for manufacturability into product development.

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28 Assurance Jobs

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8. Test Cases

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Here's how Test Cases is used in Principal Quality Engineer jobs:
  • Led SAS Base and Macro programming project to provide shared code which alleviated maintenance bottleneck by removing interdependence of test cases.
  • Composed and executed test cases for WindChill (the replacement system chosen for configuration management).
  • Author Test plans & functional test cases for new releases of SMG 10.6.0.x.
  • Authored test cases and recorded test results in Integrity Documents and Test Sessions.
  • Reviewed the test plans, test cases and scripts prepared by the team.
  • Work closely works with developers to design test cases and test plan.
  • Prepared test plans, test cases and test scripts.
  • Executed QA and UAT test cases.

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1 Test Cases Jobs

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9. QA

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high Demand
Here's how QA is used in Principal Quality Engineer jobs:
  • Provided QA input for new program development teams including manufacturing validation and process qualification process.
  • Provide leadership, guidance and expertise to the QA technology transfer team for the development and execution of qualification strategies.
  • Started as the sole QA remotely supporting an Atlanta-based development team with a reputation for untested, buggy code.
  • RESULT: Collaborated with QA team in the creation, implementation and support of a mature Nuclear Quality Program.
  • Conduct Weekly Quality meetings with CM Production / Upper Management to review QA action plans and results.
  • Created the Visiting QA Engineer invitational program to train internal customers and engineers on product usage.
  • Automated a new CASH Management project using QA Partner for Bank of Boston.
  • Managed a team of 10 onshore and 15 offshore QA Analysts.
  • Created a library of defects for easy reference by QA inspectors.
  • Manage 16 person QA Fill Finish group.
  • Coordinate daily team meetings and QA workshops.
  • Created the overall QA Operating Model.
  • Mentor to junior members of QA and R&D staffs.
  • Certified NQA-1 Lead Auditor per ANSI N45.2.23, NQA-1 1994.
  • Promoted to eHealth QA project leadership and trained successors in the U.S. and Belarus.
  • Supervised six QA inspectors on two shifts and mentored junior QEs.
  • Engineer and QA project lead on SystemEDGE agent and eHealth suites.
  • Involved in conducting trainings and facilitating QA and cross-functional meetings.
  • Write all necessary SOPs for QC testing and QA systems.
  • Write and/or revise QA SOPs.

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3 QA Jobs

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10. Validation Protocols

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high Demand
Here's how Validation Protocols is used in Principal Quality Engineer jobs:
  • Generated and executed validation protocols for equipment and processes.
  • Write all Validation protocols and perform the validation execution.
  • Developed validation protocols (IQ/OQ/PQ), performed inspections and/or tests, analyzed results and prepared summary reports.
  • Implemented rigorous supplier qualification and validation protocols that increased first time quality by 50%.
  • Approved analytical test methods and method validation protocols and reports.

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3 Validation Protocols Jobs

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11. Process Improvement

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high Demand
Here's how Process Improvement is used in Principal Quality Engineer jobs:
  • Assessed process capabilities, innovated and implemented process improvements and optimized yield and efficiency.
  • Executed process improvements in coordination with lean activities and value improvement programs.
  • Redesigned the continuous process improvement and change management training.
  • Implemented process improvements to increase production yields.
  • Facilitated and managed Process Improvement (Cross functional) teams involving personnel from the manufacturing plant and key suppliers.
  • Process improvement included workforce reduction and moving roles to China and Romania along with training new worldwide system users.
  • Followed up with key manufacturing process improvements which improved part yield by 30%.

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1 Process Improvement Jobs

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12. FDA

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high Demand
Here's how FDA is used in Principal Quality Engineer jobs:
  • Served as team member tasked with preparation of clinical trial result package in anticipation of FDA panel presentation for PMA approval.
  • Involved in NDA submission for brain tumor imaging agent, which was granted FDA approval following a successful FDA NDA audit.
  • Participated in Notified Bodies audits of Quality Management System, FDA, customer and supplier audits.
  • Team trainer for design control compliance with European (CE Mark) and FDA/Quality System Regulations.
  • Developed a quality system to monitor product field performance in response to an FDA warning letter.
  • Supported Regulatory (FDA, LNE-GMED) audits, Corporate audits, and internal audits.
  • Performed internal audits of the deviation and customer complaint systems prior to FDA annual audits.
  • Ensured company awareness of federal regulatory rules & regulations (FDA, DoD).
  • Participated and supported on-site FDA and third party audits; performed supplier product audit.
  • Contracted and joined the Baxter International team to mitigate a failed FDA audit.
  • Qualified bulk drug substance intermediate storage container in response to FDA 483.
  • Presented these reports to FDA personnel during inspections.
  • Host FDA audits and Customer corporate audits.
  • Responded to FDA deficiency questions.
  • Performed audits for compliance to ISO 13485 and FDA QSR to cGMP for class 3 implantable medical electronic devices and accessories.
  • Major contributor in the readiness for FDA response on Juncos and Humacao sites.
  • Led FDA pre-market approval facility audit for first of its kind endovascular treatment for abdominal aortic aneurysms.
  • Updated product development procedures (PDP) to address latest FDA compliance hot-buttons .

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7 FDA Jobs

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13. New Product Development

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high Demand
Here's how New Product Development is used in Principal Quality Engineer jobs:
  • Participated in New Product Development Engineering Teams acting as a Component Engineering Focal for part selection and customer approval.
  • Collaborated with manufacturing, marketing and regulatory teams to define requirements for new product development and implementation.
  • Completed requisite documentation for 3 new product development projects.
  • Core team member of new product development projects related to EFG products.

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3 New Product Development Jobs

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14. Corrective Action

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high Demand
Here's how Corrective Action is used in Principal Quality Engineer jobs:
  • Performed statistical analysis of trended issues, internal and external, and provided feedback to management and recommended corrective actions.
  • Guide team determination and implementation of corrective actions for defective product and materials.
  • Created/implemented corrective action plans for quality system audit findings.
  • Conducted returned material root cause and corrective action analysis.
  • Performed and coordinated CAPA investigations and corrective actions.
  • Performed data trend analysis and recommended corrective actions.
  • Guide implementation of corrective actions.
  • Develop and implement the environmental corrective actions, policies and procedures for the Underground Storage Tank Control (UST) Program.
  • Perform root cause analysis of material and system discrepancies and coordinate the implementation of corrective action to prevent recurrence.
  • Participate in the development and implementation of audit corrective actions Oversee document control system in accordance with ISO/API.
  • Initiate and perform CLCA (Closed Loop Corrective Action) & 8D (Eight Discipline) Activities.
  • Lead supplier audit program, performed all assessments and corrective action follow-up action items.
  • Manage Supplier Corrective Action Requests (SCAR) for assigned suppliers / commodities.
  • Reduced mean corrective action process cycle time by a factor of 4.
  • Process Owner of the Corrective Action/Preventive Action (CAPA) process.
  • Identified issues, assembled teams and schedule corrective actions.
  • Manage and audit supplier corrective actions, implementation and effectivity.
  • Prepare approvals/disapprovals of UST regulatory or corrective action requirements.
  • Lead the supplier quality efforts thru the supplier evaluations, on site audits, corrective actions, technical reviews.
  • Implemented corrective actions when those metrics did not conform to the company s goals and objectives.

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18 Corrective Action Jobs

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15. Medical Devices

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Here's how Medical Devices is used in Principal Quality Engineer jobs:
  • Validated sterile packaging for a variety of medical devices.
  • Served as Quality Engineering Lead on global expansion projects to introduce various US Class III medical devices into Japanese market.

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4 Medical Devices Jobs

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16. R

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Here's how R is used in Principal Quality Engineer jobs:
  • Created new structures for testing and documenting subjective quality elements.
  • Lead execution of qualification and ongoing reliability testing.
  • Appointed by executive management as the management representative.
  • Generated essential design outputs and inspection and test plan in alignment with critical to quality and requirements flow-down per QSR.
  • Travel to customer sites - internationally - to prevent problems and troubleshoot issues and attend customer meetings.
  • Point of contact for returned product, leading Root Cause analysis, implementation of Corrective/Preventive actions.
  • Project manager and quality lead for NATO engineering and logistics project at Kandahar Airfield, Afghanistan.
  • Performed contract reviews, supported generation and reviews of Statement of Work (SOW).
  • Supported product development by identifying applicable standards to product design; create standards checklist.
  • Lead and coach 8D correction action teams to permanently solve difficult quality problems.
  • Guide, coach, lead, remove barriers, supervise cross-functionally.
  • Tested Product Catalog model including Authoring of Offers and Products.
  • Performed Internal audits as part of the Internal Auditor Pool.
  • Maintained reliability test methods compendium; planned and executed design verification testing.
  • Reviewed and approved validation of test methods, shelf life, sterilization, biocompatibility & packaging.
  • Used Jira for Project Management, creating sub tasks for testing activities.
  • Provided mentorship and supervision to junior staff members.
  • Assessed applicability of clauses of 45502, 62304, 14708, 60601, [ ] and 93/42/EEC to new products.
  • Used tools such as Fish bone, 8D, CAMP & Mistake proofing, 5 why etc.)
  • Run charts, Cpk, normality plots etc.)

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17. Sigma

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Here's how Sigma is used in Principal Quality Engineer jobs:
  • Implement continuous improvement strategies via six sigma methodologies.
  • Acted as 6 Sigma Project Lead for a lens improvement project that resolved a major quality concern for Kodak Health Imaging.
  • Provided plant and corporate wide training in the use of the Six Sigma tools.
  • Served as a change leader to deploy Lean Six Sigma culture and methodology.
  • Trained and developed suppliers to successfully implement the Six Sigma Quality Program.
  • Initiated Six Sigma Certification Program - Selected and approved Green Belt coursework.
  • Mentored and coached project leaders to effectively apply Lean Six Sigma.
  • Led Six Sigma projects to improve business processes.
  • Provided technical support on six sigma principles.
  • Prepare 8D reports Use Six Sigma tools to improve process control.

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13 Sigma Jobs

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18. Fmea

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Here's how Fmea is used in Principal Quality Engineer jobs:
  • Review and approve ECR's, FMEA/CIL's, Manufacturing Work Orders and verified configuration control.
  • Developed and maintained product safety risk management files including design/process risks FMEA and user risks.
  • Lead Process & Design Failure Mode and Effects Analysis (FMEA) events.
  • Developed component test plans based on DHF and DFMEA.
  • Led implementation of FMEA & Product Safety Reviews.
  • Use of FMEA, IPC-610 documents and processes.
  • Implement process test limits based on statistical analysis Lead team that produced Process PFMEA
  • Directed process FMEA and optimized BGA Underfill application.
  • Process Flow diagram, FMEA and PCP-Process Control Plan) Performed initial and statistical process studies using Minitab.

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5 Fmea Jobs

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19. Management System

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Here's how Management System is used in Principal Quality Engineer jobs:
  • Assured that all products met contractual quality and configuration requirements and complied to Honeywell's Quality Management System.
  • Improved overall Configuration Management system for better results in maintainability & availability.
  • Managed and instituted new Quality Management System audit program.
  • Focus on product development, utilizing matrix management system.
  • Integrate certification transitions with complex quality management systems.
  • Implemented the effectiveness of quality management systems.
  • Support and develop company quality management system.
  • Delivered all aspects of training management system upgrade, for global department of ~2500 scientific and non-scientific staff.
  • Create and update quality system documentation in support of the Quality Management System.
  • Performed quality management system audits to ISO 9002 standards.

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12 Management System Jobs

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20. Data Analysis

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Here's how Data Analysis is used in Principal Quality Engineer jobs:
  • Performed data analysis to identify potential areas for improvement.
  • Mentored other Kodak engineers in BlackBelt techniques, data analysis, and planed DOEs.

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2 Data Analysis Jobs

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21. MRB

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Here's how MRB is used in Principal Quality Engineer jobs:
  • Enhance and improve the MRB(material review Board) process to return discrepant parts to vendor.
  • Provide quality engineering support to manufacturing, Quality Systems, Inspection planning, Tooling acceptance, MRB.
  • Reduced and maintained the MRB backlog from greater than 130 to under 5.
  • Participate in MRB action for defective product and materials.
  • Review and disposition material submitted to MRB.
  • Established a series of CAPA Programs (MRB, SCAR's, CAR's, CCR's).

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1 MRB Jobs

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22. SPC

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Here's how SPC is used in Principal Quality Engineer jobs:
  • Ported paper SPC to computer based systems in three manufacturing areas by collaborating with Information Systems group.
  • Developed, implemented and managed Statistical Process Control (SPC) programs with key suppliers.
  • Trained over 250 individuals for the conversion to Infinity SPC throughout the entire plant.
  • Implement shop floor SPC and provide plant-wide statistics support.
  • Implement shop-floor SPC and provide plant-wide statistics support.
  • Review and evaluate SPCC plans for various facilities.

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23. QMS

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Here's how QMS is used in Principal Quality Engineer jobs:
  • Delivered monthly QMS status to Senior Management and conducted a formal Management Review.
  • Provide quality leadership / guidance on all QMS matters as well as product compliance to the facility.
  • Assured the quality objectives were set by the top management for measuring the QMS performance.
  • Executed supplier QMS audits and assessments, QMS improvement projects, and corrective actions.
  • Trained suppliers for validation and audited QMS for ISO 13485, 9001 regulations.
  • Provided corporate program technical leadership of QMS & EH&S compliance.
  • Instituted many Hydra program quality policy and procedure improvements into AS9100 QMS.
  • Produced QMS performance data for regular top management reviews.
  • Process owner of key QMS processes.
  • Lead Auditor for AS-9100C QMS, responsible scheduling and Corrective / Preventive actions implementation and effectiveness verification.

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24. Material Review

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Here's how Material Review is used in Principal Quality Engineer jobs:
  • Led nonconforming material investigations and presented dispositions to material review board.
  • Manage Non-Conforming Material Process including chairing Material Review meetings.
  • Review and disposition SMRR's (Supplier Material Review Request).
  • Developed standard repairs and lead the Material Review Board.

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10 Material Review Jobs

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25. Customer Complaints

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Here's how Customer Complaints is used in Principal Quality Engineer jobs:
  • Drive internal teams on resolution of customer quality issues and ensure timely closure of all customer complaints.
  • Direct link for Customer Complaints issued through Product Surveillance.
  • Facilitated strategies to reduce closure time for customer complaints.
  • Appointed lead to investigate and resolve customer complaints.
  • Provide support to resolve customer complaints.
  • Lead multi-disciplinary team CAPA/PA investigations, and responsible for the investigation and resolution of Customer Complaints.

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26. Engineering Support

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Here's how Engineering Support is used in Principal Quality Engineer jobs:
  • Provide quality engineering support in project design, development and implementation phases.
  • Provide quality-engineering support for Design Reviews.
  • Provided Program Quality Engineering support to the Boeing EKV product line.
  • Provided Quality Engineering support for major accounts at the Salem facility.
  • contract to direct) Provide direct quality engineering support to the Digital Scanner development and manufacturing.

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2 Engineering Support Jobs

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27. Customer Service

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Here's how Customer Service is used in Principal Quality Engineer jobs:
  • Support and investigate Customer Service for CM related issues.
  • Created portal for Marketing and Customer Service to access searchable database as needed.

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28. Process Control

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Here's how Process Control is used in Principal Quality Engineer jobs:
  • Implemented Statistical Process Control tools to monitor production processes.
  • Resolved 99% of open findings and implemented 17 Process Control Documents in four months.
  • Implemented process controls that avoided any quality and product issues during commercialization of the product.
  • Instituted trigger levels to establish process control and problem solving methods to maintain control.

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1 Process Control Jobs

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29. Customer Requirements

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Here's how Customer Requirements is used in Principal Quality Engineer jobs:
  • Authored Quarterly FRACA Summary Reports per customer requirements using ORACLE Discoverer.
  • Lead product team compliance with customer requirements in an ISO-9000, AS9100 defense/aerospace environment.
  • Identified critical customer requirements (CCR) to improve customer satisfaction.
  • Developed accept/reject criteria based on identified critical features and customer requirements.
  • Reviewed contracts and POs and supported the awareness of customer requirements throughout the company.

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30. QC

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low Demand
Here's how QC is used in Principal Quality Engineer jobs:
  • Identify project/contract QA/QC resource level and competence requirements.
  • Monitor Outgoing Quality Control (OQC) and Customer Audit (CA) processes at OEM sites.
  • Manage the review and approval of Batch Production and QC records.
  • Prepare QA/QC manuals, plans, and procedures.
  • Order Supplies and Equipment for the QC Lab.

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31. OQ

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low Demand

32. Design Verification

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Here's how Design Verification is used in Principal Quality Engineer jobs:
  • Provide responses to design verification and quality engineering submission deficiencies.
  • Authored Quality and Design Verification Master Plans.
  • Planned and implemented design verification tests (DVT), thermal performance characterization, and durability tests.
  • Performed reliability testing (HALT, HASS, MTBF) and design verification testing.
  • Reviewed, edited and approved change requests, marketing specifications, product specifications, design verifications and design validations.

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33. GMP

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Here's how GMP is used in Principal Quality Engineer jobs:
  • Assisted in designing GMP Manufacturing Lab and Raw Material, In-Process, and Finished Goods Control Areas.
  • Lean Manufacturing, GMP & MDD regulations, auditing, regulatory compliance & statistical analysis.
  • Supervised Quality technicians to provide GMP and process training.
  • Educated and influenced teams to design for pharmaceutical and cGMP compliance.
  • Coached engineers in medical device cGMP and regulatory standards.
  • Audit all departments for cGMP compliance.

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2 GMP Jobs

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34. As9100

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Here's how As9100 is used in Principal Quality Engineer jobs:
  • Prepared organization for AS9100C certification audit.
  • Managed team of 5 quality auditors to ensure 300 person operation was AS9100 compliant and audit ready.
  • Perform internal audits to AS9100C and Lockheed Martin Nuclear Weapon Standards.
  • Received AS9100C Lead Auditor certification 2013 (AQS).
  • Conducted supplier audits against ISO and AS9100 standards.
  • Perform Internal audits to AS9100 requirements.
  • Performed internal audits to the AS9100C standard and identified nonconformance and areas of weakness.

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35. CFR

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Here's how CFR is used in Principal Quality Engineer jobs:
  • Performed supplier audits and Commercial Grade Surveys, certified as a nuclear lead-auditor, chair for 10CFR Part 21 screening committee.
  • Assured that development teams met quality requirements (21 CFR 210, 211, 820 and ISO 13485).

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3 CFR Jobs

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36. IQ

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low Demand
Here's how IQ is used in Principal Quality Engineer jobs:
  • Led process improvements (internal and external), involving the creation/application of new and/or existing process improvement tools and techniques.
  • Utilized Six Sigma Black Belt techniques to define, monitor, analyze, improve, and control all internal processes.
  • Analyze and solve unusually complex problems that require sophisticated analysis and research techniques to lead a project to completion.
  • Assisted in the identification of better equipment and lab measurement techniques for analysis of lens quality.
  • Improved quality achievement and performance by training in problem solving techniques and CA plan development.
  • Approved and edited equipment IQ, OQ, and PQ protocols and reports.
  • Approved process qualification documents (IQ, OQ, and PQ).
  • Prepared and executed IQ's and OQ's for QC laboratory equipment.
  • Applied Quality Engineering techniques and tools (Six Sigma, etc.)
  • Incorporated DMAVD 6 Sigma techniques for new products.
  • Trained all lab users in new remote-access techniques.
  • Improved maintenance standards by introducing new techniques and analytical analyses.

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2 IQ Jobs

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37. Minitab

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low Demand
Here's how Minitab is used in Principal Quality Engineer jobs:
  • Worked with team to develop design V & V protocols and reports and IQ/OQ/PQ protocols using Minitab as one tool.

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38. Quality Metrics

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Here's how Quality Metrics is used in Principal Quality Engineer jobs:
  • Monitored Quality metrics worldwide including inputs and total cost of quality and customer satisfaction survey results.
  • Developed, applied and carefully monitored quality metrics.
  • Compiled and presented the monthly Quality Metrics to the business units and senior managers to aid in prioritizing continuous improvement projects.
  • Defined, measured, analyzed, and implemented action to improve quality metrics.
  • Calculate and report program Quality metrics and KPI's.
  • Lead periodic Quality Metrics Meeting.

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39. CE

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low Demand
Here's how CE is used in Principal Quality Engineer jobs:
  • Developed a Supplier Performance Improvement Strategy and actively collaborated in the development and implementation of Supply Chain Management's Scorecard.
  • Supported safety testing for product certifications and was a member of review panel for product submissions to regulatory authorities.
  • Performed reliability characterization, acceptance testing, test parameters and sample size determination.
  • Performed reliability prediction calculation; generated accelerated life and HALT reports.
  • Developed and maintained AS9100 system for aerospace manufacturing operations.
  • Develop, document, implement and maintain Quality Management System processes in areas of quality planning, control, and improvement.
  • Reviewed all customer support calls and service records for possible complaints and processed complaints in a uniform and timely manner.
  • Validated Publication of Products with attributes Price, Price Value, Pricing Elements, Offers, Product Groups.
  • Reduced RMA return cycle time by 50% by developing, documenting, implementing a streamlined process.
  • Validated Products on the Store Front for end user and validated Checkout Process/flow of Shopping Cart.
  • Improved two quality system procedures for identification, analysis, correction, and prevention of defects.
  • Received two spot light rewards for exceeding expectations and exhibiting excellence in execution of goals.
  • Based on the requirements and acceptance criteria created/updated Test Cases for Offers.
  • Involved in Sprint Retrospective after iteration to improve the Process.
  • Manage QA Lab and outsourced lab services and expenses.
  • Budget and plan new equipment and resources.
  • Certified Lead Auditor (ANSI N45.2.23 and NQA-1-1994 Ed.)
  • Procedurlized inferential and descriptive statistics and reliability test program.
  • Validated for Requirement Traceability Matrix.
  • Participated in Kaizens for the MCDU production cell to improve layout and reduce touch labor.

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40. DHF

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low Demand
Here's how DHF is used in Principal Quality Engineer jobs:
  • Review DHF documents under the guidance of lead Program Quality Engineers.
  • Audited and managed Design History Files (DHF)
  • Audited DHF deliverables and supplier quality per quality management system and QSIT guidelines; supported third party audits.

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41. Risk Analysis

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Here's how Risk Analysis is used in Principal Quality Engineer jobs:
  • Led design review and risk analysis for product line introduction to US market from Germany.

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1 Risk Analysis Jobs

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42. Risk Assessments

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low Demand
Here's how Risk Assessments is used in Principal Quality Engineer jobs:
  • Created, reviewed and approved risk assessments.
  • Conducted business risk assessments and provided technical support and guidance using numerous problem solving tools (i.e.

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43. QSR

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low Demand
Here's how QSR is used in Principal Quality Engineer jobs:
  • Develop Quality Systems in compliance with the QSR, ISO 13485:2003, ISO 14971:2007 and other medical device regulations.
  • Ensured compliance of design history files to QSR and ISO 13485 requirements.

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44. Quality Support

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Here's how Quality Support is used in Principal Quality Engineer jobs:
  • Provided quality support on system harmonization effort (consolidating multiple quality system into a single quality system).
  • Provided quality support to process and quality improvement projects.
  • Improved customer confidence in the organization and quality of the product while decreasing quality support by half.
  • Provided quality support for heart leads development programs.
  • Provide Pharma quality support for new analytical laboratory.

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45. Dcma

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Here's how Dcma is used in Principal Quality Engineer jobs:
  • Developed and obtained approval for standard repair from DCMA which reduced the cycle time for repairs by 75%.
  • Interfaced with DCMA (Defense Contract Management Agency) and defense customers.
  • Support DCMA on-site product reviews.

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46. Control Board

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low Demand
Here's how Control Board is used in Principal Quality Engineer jobs:
  • Assessed Engineering Changes for accuracy, effectiveness and compliance and provided support to the Change Control Board process.
  • Developed a change control board to monitor and manage product changes.
  • Acted as the compliance representative on Cordis Change Control Board to review changes made to Cordis Franchise Documents.

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47. OEM

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Here's how OEM is used in Principal Quality Engineer jobs:
  • Provided input at management reviews where supplier/OEM issues discussed, advising management of potential risks and made recommendations.
  • Conduct periodic reviews of Field/Factory Quality Data with OEM partners and weekly/monthly Product summary.
  • Worked with OEM supplier for UL Certification process, employee training and record keeping practices.
  • Assist BSC division in complaint investigations in conjunction with OEM finished good suppliers.

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48. DOE

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low Demand
Here's how DOE is used in Principal Quality Engineer jobs:
  • Performed scientific validations including DOE's and statistical analysis.
  • Drive site evaluations and continuous performance improvement, and improves the way the Site does business.

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49. SME

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low Demand
Here's how SME is used in Principal Quality Engineer jobs:
  • Developed accreditation strategies for risk assessment and competency training across global R&D and commercial manufacturing business lines.
  • Consult with team regarding medical device process/risk assessments and validations.
  • Facilitated supplier quality development initiatives; conducted supplier assessment audit.
  • Authored plans and reports for Project Quality, V&V, Design History File Assessments, Change Assessment collaboration.
  • Conducted due diligence assessment of new suppliers, led cross-functional assessment teams at numerous domestic as well as international suppliers.
  • Led Audit Teams that conducted Quality Systems audits and product-focused, risk-based assessments of various products at OEM manufacturing locations.
  • Developed a Supplier Controls program, including an Approved Vendor List, with a Supplier Assessment program.
  • Work closely with marketing and operations to maximize NMBM throughput for the Smelter and Refinery business units.
  • Acted as the subject matter expert (SME) for numerous internal data systems and conducted training.
  • Support supplier contract compliance assessments of supplier internal processes, procedures, and quality management system.
  • Provided direction to QC, project management, risk assessment and resolution per FRACAS compliance.
  • Supported health hazard evaluation (HHE) process; conducted patient safety and risk assessment.
  • Provided key support and guidance for organizations readiness and passing of Airbus IPCA assessment.
  • Viewed as the expert in issue spotting, assessment and analysis by peers.
  • Keep stakeholders informed of testing status, and provide assessment of deployment readiness.
  • Involved in supplier audits, assessments, supplier qualification and quality issues.
  • Managed and was the Lead Auditor for facility internal assessment program.
  • Trained and monitored plant personnel to support assessment program.
  • Perform audits, product assessments and compliance assurance.
  • Reviewed independent assessment audit results for safety and quality requirements flowdown from NASA Headquarters to Marshall Space Flight Center.

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50. Ppap

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low Demand
Here's how Ppap is used in Principal Quality Engineer jobs:
  • Well-versed in AQL, Six Sigma, PPAP, FMEA, TQM and other Quality Management techniques.
  • Instituted Production Part Approval Process (PPAP) requirements with select suppliers.
  • Implemented PPAP for a non automotive facility.

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1 Ppap Jobs

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20 Most Common Skills For A Principal Quality Engineer

Product Quality

17.4%

Ensure Compliance

11.5%

Audit Procedures

11.4%

Supplier Quality

8.6%

ISO

4.8%

Capa

4.3%

Assurance

4.3%

Test Cases

3.9%

QA

3.7%

Validation Protocols

3.6%

Process Improvement

3.6%

FDA

3.3%

New Product Development

3.1%

Corrective Action

2.7%

Medical Devices

2.6%

R

2.6%

Sigma

2.5%

Fmea

2.3%

Management System

2.1%

Data Analysis

1.7%
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Typical Skill-Sets Required For A Principal Quality Engineer

Rank Skill
1 Product Quality 13.7%
2 Ensure Compliance 9.1%
3 Audit Procedures 9.0%
4 Supplier Quality 6.8%
5 ISO 3.8%
6 Capa 3.4%
7 Assurance 3.4%
8 Test Cases 3.1%
9 QA 3.0%
10 Validation Protocols 2.9%
11 Process Improvement 2.9%
12 FDA 2.6%
13 New Product Development 2.4%
14 Corrective Action 2.1%
15 Medical Devices 2.1%
16 R 2.0%
17 Sigma 2.0%
18 Fmea 1.8%
19 Management System 1.6%
20 Data Analysis 1.4%
21 MRB 1.2%
22 SPC 1.1%
23 QMS 1.1%
24 Material Review 1.1%
25 Customer Complaints 1.0%
26 Engineering Support 0.9%
27 Customer Service 0.9%
28 Process Control 0.9%
29 Customer Requirements 0.9%
30 QC 0.8%
31 OQ 0.7%
32 Design Verification 0.7%
33 GMP 0.7%
34 As9100 0.7%
35 CFR 0.7%
36 IQ 0.7%
37 Minitab 0.6%
38 Quality Metrics 0.6%
39 CE 0.6%
40 DHF 0.6%
41 Risk Analysis 0.6%
42 Risk Assessments 0.6%
43 QSR 0.5%
44 Quality Support 0.5%
45 Dcma 0.5%
46 Control Board 0.5%
47 OEM 0.5%
48 DOE 0.5%
49 SME 0.4%
50 Ppap 0.4%
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