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

* Other duties, as required

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

LOCATION: