Principal Engineer Supplier Quality(SQE)
Core
Driving supplier quality performance and compliance for life sciences, diagnostics, and biotechnology products through qualification, monitoring, and corrective actions.
Role type
Principal Engineer, Supplier Quality (SQE)
Builds
Reliable medical device and diagnostic products for global life science customers
Domain
Life Sciences / Medical Devices / Diagnostics / Biotechnology
Deliverable
client delivery
Required skills
Supplier qualification and management, Root cause analysis, Audit leadership (internal/external), ISO 9001/13485/GMP/FDA compliance knowledge, Continuous improvement (Kaizen/PSP/Poka-yoke), Failure analysis, KPI monitoring
Preferred skills
Electrical/Electronics/Mechanical Engineering degree, 5-8 years Supplier Quality Management experience, Medical device manufacturing operations knowledge, Lead-auditor certification, Problem solving tools (5 Why, DFM, PFMEA, GR&R, Control Plan, SPC)
Responsibilities
Lead supplier qualification activities for new suppliers, Monitor supplier performance and review quality data/scorecards, Drive resolution of complex material quality issues via root cause analysis, Lead continual improvement initiatives to improve KPIs, Support and participate in internal audits and regulatory compliance activities, Ensure China site compliance with ISO9001, ISO13485, FDA 21 CFR Part 820, and China NMPA requirements
Seniority
Principal, hands-on IC with strategic oversight