Senior Supplier Quality Engineer - SFMD
Core
Oversees a global network of suppliers manufacturing finished medical devices, ensuring patient safety and improving supplier manufacturing processes.
Role type
Senior Supplier Quality Engineer (Medical Devices)
Builds
Finished medical devices for distribution (via careerplan.io/jobs/563602813035570-senior-supplier-quality-engineer-sfmd-at-bostonscientific)
Domain
Medical Device Manufacturing / Quality Engineering
Required skills
systematic problem-solving, corrective action plan review, supplier auditing, process validation, design controls, risk management, CAPA management, cross-functional project management, 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 using systematic methodologies; plan and lead supplier audits for regulatory compliance; lead onboarding of finished medical device suppliers; generate and review quality plans and product specifications; develop and implement quality system policies and procedures.
Seniority
Senior, hands-on IC
