Requires 2 years of experience in the following skillsbr br Leading and managing CAPA Investigation and Root Cause Analysis;br Medical DeviceGMP experience in Quality Management System QMS in the execution and implementation of subsystems such as CAPA, Nonconforming Process and Complaint Handling;br Clinical Laboratory experience with CAP, CLIA, NYSDOH and LDT;br Electronic document control and change control requirements and systems such as Veeva, MasterControl, Agile, and SAP;br Interpreting FDA requirements such as 21 CFR PART 820 and ISO 13485 and other regulatory requirements from CAPCLIANYSDOH.br Telecommuting is permissible.br Employment and background checks may be required.

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