Manager, Medical Device External Quality
Core
Oversees external product quality assurance (EPQA) for commercial medical devices manufactured by third parties, ensuring compliance with specifications and regulatory requirements.
Role type
Manager, Medical Device External Quality
Builds
Commercial medical devices and components produced by Contract Manufacturing Organizations (CMOs) and third-party suppliers
Domain
Medical Devices / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Assurance Operations Management, supplier quality management, CAPA/NCR management, change control, complaint handling, product release, supplier audit, KPI development, trend analysis, technical protocol review, regulatory inspection support
Preferred skills
New Product Introduction (NPI) support, transfer-to-manufacturing expertise, global Product Quality Assurance strategy development
Technologies
Sterile, biological, liquid, ointments, devices, solid tablets, caplets, suspensions, granulations, soft elastic capsules, gel caps, extended release products, coating solutions, active pharmaceutical ingredients
Responsibilities
Manage CMOs and third-party suppliers to assure timely and compliant release of commercial products; Oversee documentation and resolution of non-conformances, CAPAs, reworks, and deviations; Support Late-Stage Development and New Product Introduction activities; Develop and maintain supplier Quality Technical Agreements; Review and approve changes to supplier processes and technical protocols; Support Regulatory inspections as a product SME; Participate in global Product Quality Assurance strategy development; Perform final quality release of manufactured product lots; Interface with Global Quality Assurance audit team to develop audit plans and maintain corrective action timetables; Lead quality reviews with Third Party Manufacturers to address operational issues
Seniority
Manager, hands-on leadership