Sr Eng, Supplier Quality
Core
Partner with suppliers to ensure externally sourced materials meet regulatory and quality standards, investigate quality issues, and drive continuous improvement.
Role type
Senior Supplier Quality Engineer
Builds
Supplier quality performance, compliance with global standards, and product quality
Domain
Medical device manufacturing / Healthcare
Required skills
Supplier quality audits, SCAR management, root cause analysis (5 Whys, Fishbone), FDA 21 CFR Part 820, ISO 13485, ISO 9000, cross-functional collaboration, data analysis
Preferred skills
ISO 13485 Lead Auditor certification, supplier development, stakeholder influence
Technologies
FDA 21 CFR Part 820, ISO 13485, ISO 9000
Responsibilities
Lead supplier quality performance monitoring, conduct supplier audits, investigate quality issues and implement corrective actions, manage SCARs, analyze supplier quality metrics, collaborate with Manufacturing and Quality teams
Seniority
Senior, hands-on IC