Supports the Distribution Quality team by applying the Quality Body-of-Knowledge for post-production quality assurance programs, policies, processes, procedures and controls for medical devices, drug/device combination products, filtration products, and purchased finished goods.

Works with moderate work direction, and can identify issues/problems but may need assistance in resolving.

Driving improvement opportunities to proactively ensure internal distribution center and 3rd party Distributor compliance to all applicable internal, domestic, and international quality regulations and competent authority requirements, including but not limited to, US 21 CFR 210, 211, and 820, ISO 13485, ISO 14971, EU MDR, Health Canada, ANVISA, COFEPRIS, MHRA, TGA, NMPA, PMDA, etc.

Executing projects and efforts to ensure area and country-level quality system and competent authority compliance for distribution center product quality assurance, material storage requirements, local l...