Quality Associate
Core
Perform final product inspection, bioburden reduction, and external sample testing for medical devices while supporting Quality Assurance activities including batch record review and document control.
Role type
Quality Associate (Medical Device Manufacturing)
Builds
Safe, compliant, and high-quality medical devices (structural heart/TAVR valves)
Domain
Medical device manufacturing / Structural heart
Required skills
Visual inspection, bioburden reduction, batch record review, document control, GMP compliance, quality investigations, internal auditing, CAPA support, root cause analysis
Preferred skills
Science or laboratory techniques qualification, experience in regulated manufacturing, strong attention to detail, analytical and problem-solving skills, organizational skills
Technologies
None explicitly stated
Responsibilities
Perform visual inspection of final product, perform bioburden reduction process, coordinate external sample testing, review batch manufacturing records, generate and control batch records and labels, support document control, review GMP records, document and investigate quality issues/non-conformances, participate in CAPA investigations, conduct internal audits, support internal and external audits, collaborate to resolve quality issues, identify process improvement opportunities
Seniority
Individual Contributor, entry to mid-level