Supplier Quality Engineer
Core
Manage supplier qualification, audits, performance monitoring, and CAPA resolution for medical device and optical component suppliers to ensure global quality compliance.
Role type
Senior Supplier Quality Engineer (Medical/Optical)
Builds
Approved Supplier Lists, Quality Agreements, Audit Plans, CAPA/SCAR resolutions
Domain
Medical Devices / Optical Manufacturing / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Supplier qualification, Supplier audit execution, CAPA/SCAR management, Supplier performance monitoring, APQP/NPI support, Quality agreement negotiation, Statistical process control (SPC), Gage R&R/MSA, Risk assessment (ISO 14971), Process validation (IQ/OQ/PQ), 8D problem solving, Global supplier management
Preferred skills
ISO 13485/MDSAP/EU-MDR regulatory knowledge, Plastic injection molding expertise, Cleanroom environmental monitoring, Cold-chain logistics management, Power BI data analysis, Lean/Six Sigma certification, Early supplier engagement, Non-BOM supplier management
Technologies
Power BI, ISO 13485, ISO 9001, ISO 14971, APQP, PPAP, FMEA, Control Plan, GD&T, IQ/OQ/PQ
Responsibilities
Execute supplier qualification processes and maintain global/local Approved Supplier Lists, Conduct and lead supplier audits with on-time closure of findings, Drive CAPA/SCAR resolution for supplier-caused quality issues, Monitor supplier performance across Business Units monthly, Participate in external/internal SQM and purchasing control audits, Collaborate with R&D on NPI projects to ensure on-time APQP deliverables
Seniority
Senior, hands-on IC