Supplier Quality Engineer
Core
Ensuring compliance of supplier controls with medical device regulations (ISO 13485, MDSAP, EU MDR) and managing supplier quality processes.
Role type
Senior Supplier Quality Engineer (Process Owner)
Builds
Supplier quality business processes and compliance frameworks
Domain
Medical Devices / Regulatory Quality
Required skills
Supplier auditing (Lead Auditor), CAPA management, SCAR management, Supplier selection and evaluation, Regulatory compliance (21 CFR 820, ISO 13485, EU MDR, MDSAP), Project management, Data analysis
Preferred skills
Master's degree in Engineering, EUMDR/QMSR Lead Auditor certification
Technologies
Trackwise, SAP, Excel, Windows
Responsibilities
Conduct supplier audits as Lead Auditor, Run Supplier Monitoring Boards, Lead internal CAPAs and high-visibility SCARs, Guide Purchasing on quality elements of supplier agreements, Support Internal and External Audits (FDA, MDSAP, EU MDR), Provide guidance on NPI supplier selection and onboarding
Seniority
Senior, hands-on IC with process ownership