Supplier Quality Engineer II
Core
Conduct supplier audits, qualify new suppliers, and monitor supplier performance to ensure regulatory compliance for structural heart devices.
Role type
Supplier Quality Engineer
Builds
Supplier qualification and performance monitoring for structural heart device manufacturing
Domain
Medical devices / Structural heart disease / Quality Assurance
Deliverable
client delivery
Required skills
Supplier audit execution, CAPA management, ISO/QSR knowledge, supplier performance monitoring, regulatory compliance analysis, technical writing
Preferred skills
ISO lead auditor certification, 5+ years QA experience in regulated industry
Technologies
ISO standards, QSRs
Responsibilities
Develop and execute supplier audit schedules, approve and monitor Supplier CAPA plans, qualify new suppliers, analyze supplier metrics for CAPA boards, issue SCARs for corrective actions, collaborate with Design, Manufacturing, and Purchasing teams
Seniority
Mid-level IC