The Supplier Quality department plays a critical strategic role in ensuring externally sourced components meet stringent medical industry quality and regulatory standards
Job Summary
The Supplier Quality department plays a critical strategic role in ensuring externally sourced components meet stringent medical industry quality and regulatory standards.
Candidates will design supplier quality management systems, perform qualification audits, manage corrective actions, and chair supplier review meetings to ensure transparency.
Success requires demonstrated mastery of structured problem-solving methodologies like 8D and 5 Why to lead complex cross-functional investigations and drive sustainable corrective actions.
Matching Summary
The Supplier Quality department plays a critical strategic role in ensuring externally sourced components meet stringent medical industry quality and regulatory standards.
Skills & Requirements
Must-have
21CFR Part 820 knowledge
ISO 13485 standards
Supplier audit leadership
DFMEA and PFMEA expertise
Structured problem solving (8D)
Six Sigma and Lean methodologies
Nice-to-have
Mentoring junior engineers
Cross-functional collaboration
Data-driven decision making
International travel capability
Design team participation
Key Requirements
Experience with molding and metal processing
Knowledge of APQP, PPAP, SPC, MSA
Formal training or certification in quality auditing