Staff Supplier Quality Engineer
Core
Lead supplier quality activities to ensure compliance with FDA regulations, ISO standards, and internal quality policies, preventing non-conforming parts from entering operations.
Role type
Staff Supplier Quality Engineer
Builds
Supply chain quality compliance and continuous improvement programs
Domain
Medical device manufacturing / Regulatory Quality
Required skills
Supplier quality management, Corrective and Preventive Actions (CAPA), Supplier audits, Process capability analysis, Six Sigma, Risk management, Validation, Change control, Statistical analysis (SPC, DOE, FMEA), Regulatory compliance (21 CFR 820, ISO 13485)
Preferred skills
IVD manufacturing experience, Quality certification (CQE), Design controls, Failure investigation tools, International travel
Technologies
SPC, Six Sigma, FMEA, DOE, Value stream mapping, 5S, Kaizen
Responsibilities
Lead activities to improve material quality from suppliers and manage long-term supplier relationships; Initiate supplier improvement projects using Six Sigma and process analysis; Conduct supplier audits to verify regulatory compliance; Monitor and improve key Supplier Quality metrics including SCAR and Assembly Yield; Travel to supplier locations to resolve quality problems.
Seniority
Staff, hands-on IC with strategic oversight