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.

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.

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.).