Katalyst Healthcares and Life Sciences
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.
- 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.).