Supplier Quality Engineer
Core
Manage supplier qualification, audits, performance monitoring, and CAPA resolution for medical device and optical lens manufacturing.
Role type
Senior Supplier Quality Engineer (Medical Devices/Optics)
Builds
Approved Supplier Lists, Quality Agreements, and compliant supply chain for Vision Care Systems
Domain
Medical Technology / Optical Manufacturing
Required skills
Supplier qualification, Audit execution (on-site/remote), CAPA/SCAR management, APQP/NPI, Statistical Process Control (SPC), Gage R&R/MSA, ISO 13485/9001 knowledge, Risk Assessment (ISO 14971), 8D problem solving
Preferred skills
ISO 13485/MDSAP/EU-MDR certification, 6 Sigma Green Belt, Lean, Power BI, Cleanroom monitoring, Cold-chain logistics, Global supplier management
Technologies
Power BI, ISO 13485, ISO 9001, MDSAP, EU-MDR, ISO 14971, APQP, PPAP, FMEA, GD&T
Responsibilities
Execute supplier qualification processes, conduct and report supplier audits, drive CAPA/SCAR closure, monitor supplier performance, participate in purchasing control audits, maintain Approved Supplier Lists, collaborate on NPI/APQP projects
Seniority
Senior, hands-on IC
