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Contract Senior Quality Engineer Resume

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TECHNICAL SKILLS:

Medical Device: Quality Engineer, Design Quality Engineer, Supplier Quality Engineer, Project Manager, Software Engineer, Equipment Validation Engineer, Process Validation Engineer and Test Method Validation Engineer.

PROFESSIONAL EXPERIENCE:

Contract Senior Quality Engineer

Confidential,MN

Responsibilities:

  • Quality Engineer assigned to CAPA team to resolve current open CAPA’s. Transition team to move production to Mexico by end of 2020.
  • Created DHF review checklist and executed DHF review.
  • Created and modified existing documents to comply with ISO 13485 and internal quality requirements. New product introduction quality lead.
  • EU MDR Gap Analysis and Remediation team lead.
  • Complaint investigation from open to recall if necessary.
  • Supported Mexico transition team in understanding all processes from dock to stock.
  • Mentored/Coached recent college graduates in medical device quality requirements.
  • Plant closing on time and under budget.

Contract Senior Supplier Quality Engineer

Confidential,Flanders NJ

Responsibilities:

  • Quality and Supplier Quality responsible for supporting new product introduction at suppliers and internal manufacturing. CAPA team lead from opening, closing and effectiveness verification. Internal and external supplier auditor.
  • EU MDR 2017 team member for reviewing and crating checklist of required changes necessary to meet new requirements. EU MDR 2017 change leader for labeling. Subject Matter Expert for review of supplier capabilities including: castings, machining, plastics, stampings, electrical harnesses, electro - mechanical, assembly, heat treating and plating. Audited suppliers per yearly and bi-annual schedule.

Contract Senior Quality Engineer

Confidential,Cornelia GA

Responsibilities:

  • Reviewed TMV reports from development through validation for equipment, chemical and software within manufacturing and internal lab.
  • Provided guidance and support for CAPA and NC process.
  • Collaborated with other Confidential sites domestically and overseas on TMV improvements and procedurals revisions to compendial or other methods. R&D and internal test lab quality oversite validation lead for protocols to reports.Contract Senior Quality Engineer: DHF Review, Validations and CAPA / NC Team
Contract Supplier Quality Engineer

Confidential, Covington GA

Responsibilities:

  • Review of DHF and developed checklist of documents to be created or revised. Initiated documentation and tracked through approval and implementation. Risk assessment team member for NPI and post market.
  • CAPA and NCR team for identification, closure and effectiveness verification. Developed and conducted IQ, OQ, PQ and TMV actions from protocols through reporting. Participated in internal and supplier audits. Coordinated recall activity with regulatory department.
Contract Quality Engineer

Confidential, Ann Arbor MI

Responsibilities:

  • Supplier remediation team member who met all goals under FDA consent decree, completed all tasks prior to deadline. Physically supported suppliers and facilitated their document readiness, while them on required documents. Assigned and closed CAPA’s and NCR’s on time with effectiveness verification. Created Health Hazard determinations based on investigations for potential collision with products and associated documentation. Coached and trained suppliers on IQ, OQ, PQ and TMV execution both internally and externally.

Contract Validation Project Engineer

Confidential, Warsaw IN

Responsibilities:

  • Reported to V.P Quality managing at risk suppliers. Remediation activities included equipment, process and TMV validations, from creating to executing protocols through reporting.
  • Validations included, cleaning, laser marking, labeling, sterile barrier packaging, machining, seal strength, ETO and GAMMA sterilization. Mentored junior validation, manufacturing and production team members in validation methods.

Confidential,Arvin CA

Responsibilities:

  • Responsible for CAPA’s, NC investigation through closure. Created Master Validation Plan and was assigned as Project Manager for risk- based prioritization and execution of MVP. Coordinated validation execution of California and offshore facilities.
  • Wrote protocols and summary reports for IQ, OQ, PQ and TMV’s. Reviewed and approved test protocols and summary reports generated by validation engineers. Wrote and executed protocols for various lean projects. Supported supplier quality engineers for external audits and findings for schedule and unscheduled visits.

Contract Manufacturing Quality Engineer

Confidential,Murrieta CA

Responsibilities:

  • Supported new stent alloy design and manufacturing methods to improve stent fatigue properties and radiopacity.
  • Interfaced with FDA team on design controls, including rationales, protocols and validations.
  • Designed and constructed two new testing machines to meet all stent fatigue testing requirements.
  • Participated in study of cobalt-chromium alloys versus common steel alloys such as 316LN for coronary stents.
  • Managed newly internal PTFE spray coating instead of external coating.
  • Developed new method of curing PTFE using infra-red heating, reducing the cure time from 8 hours to 15 minutes. Managed feasibility study, process development / verification through design transfer to production.Toyota Supplier Support Engineer

Product Design and Release Engineer

Confidential,Erlanger K Y

Responsibilities:

  • Team leader deploying the confidential Production System (LEAN Manufacturing) and Product Development System (24 Month to Market) to  Suppliers performing and under performing in North America.
  • Deployed to non-automotive suppliers as requested to mentor and teach LEAN methods to furniture, beverage, hospitals and other companies requesting Toyota’s ‘free gift’ to North America. Master Sensei of Toyota Production and Product Development Systems.
  • Turned around under performing companies owned, partially owned or otherwise. Supported internal and external manufacturing in achieving and sustaining all LEAN activities.

Confidential,Dearborn MI

Lead engineer

Responsibilities:

Lead engineer for DSO Special Projects to advance projects teams of VN-127, PHN-131 and other truck platforms. Responsible for over 120 unique release parts from all PAT’s from body to frame. Program management responsible for niche and low volume specialty vehicles such as stripped chassis for motor homes and aftermarket delivery vehicles. Launch vehicle on time and at budget for the first time in Ford Motor Company history.

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