Supplier Quality Engineer
Core
Drive supplier performance and continuous improvement for Image Guided Therapy Devices, ensuring regulatory compliance throughout the product lifecycle.
Role type
Senior Supplier Quality Engineer (Medical Devices)
Builds
Approved Supplier List, Supplier Quality Agreements, validated supplier processes
Domain
Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Supplier selection and performance assessment, APQP, Risk Assessments/PFMEA, SPC, SCAR management, CAPA, Regulatory compliance knowledge (FDA/ISO), Data analytics for KPIs
Preferred skills
ASQ certification, Six Sigma DfX certification
Technologies
21 CFR Parts 803/806/820, ISO 13485, ISO 14971, EU MDR, Canadian Medical Devices Regulation
Responsibilities
Coordinate supplier improvement initiatives and negotiate Supplier Quality Agreements, Manage daily NCRs/SCARs/SCNs and the Approved Supplier List, Facilitate technical capability assessments for new suppliers, Monitor product/process quality trends and troubleshoot production issues, Conduct detailed defect analysis and act as independent reviewer for SCARs, Develop and oversee equipment qualification and process validation plans, Provide quality oversight for supplier change requests, Serve as internal and supplier quality auditor
Seniority
Senior, hands-on IC