Principal Engineer, Supplier Quality
Core
Drive supplier quality performance and compliance for mechanical and critical indirect suppliers in the life sciences and diagnostics industry.
Role type
Principal Engineer, Supplier Quality
Builds
Supplier qualification processes, quality agreements, and corrective action plans for manufacturing partners.
Domain
Life sciences, diagnostics, biotechnology, medical devices manufacturing
Required skills
Supplier qualification, root cause analysis, audit leadership (ISO9001/13485/GMP), continuous improvement methodologies (8D, 5Why, Fishbone), cross-functional problem solving, supplier performance monitoring
Preferred skills
MDSAP environment experience, manufacturing operations, lead auditor certification
Technologies
ISO9001, ISO13485, GMP, MDSAP, PFMEA, Control Plan
Responsibilities
Manage mechanical and critical indirect supplier portfolio; lead supplier qualification and NPD/NPI support; drive resolution of material quality issues; act as SQE audit lead for internal/external audits; develop continuous improvement in supplier quality processes.
Seniority
Principal, hands-on IC
