Katalyst Healthcares & Life Sciences
Quality Assurance Specialist
Katalyst Healthcares & Life Sciences, Rocklin, California, United States, 95765
Quality Assurance Specialist
Responsibilities: Support site Quality Management System (QMS) and ensure compliance of the quality system with relevant regulations, including but not limited to ISO 13485, IVDR (EU), IVDD (EU), 21 CFR part 20 and part 11, ISO 14971 and GxP. Represent Quality on cross-functional teams to support business needs and may lead quality initiatives driving positive site Quality culture.
Responsibilities: Support site Quality Management System (QMS) and ensure compliance of the quality system with relevant regulations, including but not limited to ISO 13485, IVDR (EU), IVDD (EU), 21 CFR part 20 and part 11, ISO 14971 and GxP. Represent Quality on cross-functional teams to support business needs and may lead quality initiatives driving positive site Quality culture.