Sr Quality Engineer, Supplier Quality Engineering
Core
Design and maintain supplier quality management systems to ensure externally sourced components meet stringent medical industry standards, directly contributing to product reliability and patient safety.
Role type
Senior Supplier Quality Engineer
Builds
Safe and effective medical products (continuous glucose monitoring systems)
Domain
Medical device manufacturing / Biosensing technology
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Supplier qualification audits, Supplier Quality Agreements, Corrective action management, Six Sigma, Lean manufacturing, Statistical sampling plans, DFMEA/PFMEA, ISO 13485, 21CFR Part 820, APQP, PPAP, SPC, MSA, 8D problem solving
Preferred skills
Quality auditing certification, Supplier program management, Cross-functional design team collaboration, Process improvement initiatives
Technologies
Oracle, SAP, Minitab, Microsoft Office
Responsibilities
Design and maintain supplier quality management system, Perform supplier qualification audits and monitor performance, Chair Supplier Review meetings, Establish and maintain Supplier Audit Schedule, Review and approve supplier documentation, Provide training to lower-level quality engineers, Travel internationally for audits
Seniority
Senior, hands-on IC