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Katalyst Healthcares & Life Sciences

Design Assurance Quality Engineer

Katalyst Healthcares & Life Sciences, San Francisco, California, United States, 94102

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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 ow...