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Katalyst HealthCares & Life Sciences

Supplier Quality Engineer

Katalyst HealthCares & Life Sciences, Gainesville, Florida, us, 32635

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Responsibilities: Knowledge of application of regulatory requirement including ISO 13485, FDA and international requirements. Enhanced quality system requirements (QSR) throughout business unit by improving quality process and CAPA closure. Implementing SICR- Supplier Initiated Change Requests (DCR, ECR, MCR) through Change management Process and as per ISO 13485 & CFR 21 Part 820...