Supplier Quality Engineer
Core
Ensuring supplier quality performance, compliance, and risk reduction within the medical device supply chain.
Role type
Supplier Quality Engineer
Builds
Compliant supply chain for medical devices (AEDs, ventilators, trauma kits)
Domain
Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Supplier quality management, FDA QSR, ISO 13485:2003, measurement system capability, process capability, process controls, supplier audits, corrective and preventive actions, statistical analysis tools, Design of Experiments (DOE), reading technical drawings
Preferred skills
MBA or MS, Lead Auditor Certification, Six Sigma Greenbelt
Technologies
Microsoft Office, statistical analysis tools
Responsibilities
Develop long-term vision for supplier quality, measure and report supplier performance metrics, manage supplier qualification and strategic business reviews, travel to supplier facilities for audits, lead investigation of supplier performance issues, drive continuous improvement and cost savings activities
Seniority
Mid-level, hands-on IC