Quality Associate III
Core
Own and manage assigned Quality Management System (QMS) processes supporting U.S. depot operations, serving as the primary Quality partner for process performance, compliance, risk identification, and continuous improvement.
Role type
Senior IC Quality Associate (Medical Device)
Builds
Quality system compliance and operational consistency across U.S. and Canadian depot operations
Domain
Medical device / Healthcare / Quality Assurance
Required skills
Risk-based decision-making, Root-cause analysis, CAPA management, Change control, Audit planning, Validation oversight, Regulatory compliance (FDA/ISO 13485), Technical writing, Project management
Preferred skills
Medical device industry experience, Internal Auditor certification, Lean/Six Sigma, Experience with depot/repair/service-center operations
Technologies
QMS software, FDA regulations, ISO 13485, GMP, GDocP
Responsibilities
Evaluate depot service documentation, process controls, equipment calibration, and adherence to approved procedures; Lead or provide Quality approval for investigations, nonconformances, CAPAs, and change controls; Plan and conduct risk-based depot assessments to identify systemic gaps; Drive continuous improvement initiatives and monitor quality metrics and trends.
Seniority
Senior, hands-on IC