Senior Supplier Quality Engineer - SFMD
Core
Overseeing a global network of suppliers that manufacture finished medical devices, ensuring patient safety and improving manufacturing processes.
Role type
Senior Supplier Quality Engineer
Builds
Finished medical devices for distribution
Domain
Medical device manufacturing
Required skills
systematic problem-solving, audit planning and execution, process validation, design controls, risk management, CAPA, project management, cross-functional collaboration, regulatory compliance, on-site supplier evaluation
Preferred skills
materials or service commodity team leadership, lead auditor experience (ISO 13485), ASQ certification (CQE, CBA, SSGB, SSBB)
Technologies
PLM, ERP
Responsibilities
Evaluate and resolve quality issues with suppliers, lead supplier audits for regulatory compliance, generate and review quality plans and product specifications, collaborate on onboarding finished device suppliers, develop and implement quality system policies and procedures
Seniority
Senior, hands-on IC