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Design Assurance Engineer - Medical Device

Redbock - an NES Fircroft company
San Jose, CA Full Time
POSTED ON 1/17/2025
AVAILABLE BEFORE 4/15/2025

Design Assurance Engineer - San Jose, CA

W2 only, no 3rd party or C2C

SUMMARY :

Quality Engineer needed to support product development efforts for a medical device innovator.

DUTIES & RESPONSIBILITIES :

  • Design, document and record reviews
  • Component and product QA / Design Assurance
  • Produce relevant and compliant documentation, as it pertains to ISO 13485 and 21 CFR 820

QUALIFICATIONS & REQUIREMENTS :

  • 3 years of medical device quality experience in new product development and product life cycle management
  • Solid understanding of ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate) as well as 21 CFR 820 and ISO 13485
  • Hands-on experience with quality inspections of components, subassemblies, and / or finished products.
  • Experience reviewing design documentation (drawings, specifications, DHFs, test data sheets, etc.)

    • Preferred Qualifications (in addition to what is listed above)

  • Working knowledge of risk management files such as FMEAs and hazard analysis. Solid understanding of ISO 14971 : 2019
  • Prior experience owning NCRs and / or CAPAs

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