Quality Engineer - Medical Devices Job

QUALITY ENGINEER - MEDICAL DEVICES needed for a CONTRACT opportunity with Yoh's client located in San Francisco, CA.

TOP SKILLS SHOULD YOU POSSESS:

- Statistical Programs Knowledge
- ISO 13485/14971
- Medical Device QA

WHAT YOU'LL BE DOING:

- Lead compliance activities focused on achieving and maintaining compliance with ISO 13485, MDD 93/42/EEC, CE mark and FDA QSR compliance.
- Develop and maintain Design History Files including development, risk files, verification and validation plans, supplier qualification strategy and quality agreements, manufacturing quality plan, design verification protocols and reports.
- Conduct design history file verifications at the end of each design control stage.
- Actively participate in design characterization as well as design and process validation.

WHAT YOU NEED TO BRING TO THE TABLE:

- Bachelor's degree in an engineering or scientific discipline.
- Five (5) plus years of progressive experience in medical device quality assurance.
- Two (2) plus years of experience in a quality role supporting product development and the manufacture of medical devices.
- Experience developing and maintaining Design History Files required.
- Experience using quality tools and statistical programs like Minitab, risk assessment - FMEA, DOE and SPC required.
- CQA, CQE, CQM certification strongly preferred; ASQ membership.
- Demonstrated working knowledge of 21CFR 820, ISO 13485, ISO 14971.
- Working knowledge of ISO 13485 certification and CE marking activities preferred.
- Excellent writing, math and statistical skills.
- Experience working within a virtual device manufacturing operations, managing CMOs is strongly preferred

WHAT'S IN IT FOR YOU?

Represent quality on product development teams ensuring quality procedures and regulatory requirements are met through the development phase into the commercial process.

WHAT ARE YOU WAITING FOR? APPLY NOW!

RECRUITER: WILL THOMPSON

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