Senior Supplier Quality Engineer
Core
Lead risk-based supplier quality oversight, qualification, and performance management for a global medical device supply base.
Role type
Senior Supplier Quality Engineer
Builds
Global supply chain quality compliance and reliability
Domain
Medical Devices / Regulatory Quality
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
ISO standards knowledge, FDA regulations expertise, CAPA/SCAR lifecycle ownership, statistical process control (SPC), FMEA, PPAP, APQP, supplier audit execution, technical documentation review, cross-functional negotiation
Preferred skills
Six Sigma Green Belt or higher, ASQ CQE or CSSQP certification, front/backroom FDA or ISO audit experience
Technologies
ISO 13485, ISO 9001, 21 CFR 820
Responsibilities
Lead risk-based supplier oversight across regions; own complex supplier qualifications and disqualifications; author and maintain supplier quality agreements; own the supplier scorecard program and drive SCAR/CAPA; troubleshoot in-depth vendor issues impacting multiple business units; mentor Quality Engineers and coach divisional QA on supplier controls; assist or perform audits for high-risk suppliers.
Seniority
Senior, hands-on IC with mentorship