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