Senior Quality Engineer
Core
Managing suppliers for released product engineering and manufacturing transfers by ensuring qualification documents meet company requirements and coordinating PPAP execution.
Role type
Senior Supplier Quality Engineer
Builds
Supplier qualification documentation, PPAP deliverables, and product acceptance sampling strategies
Domain
Medical device manufacturing and supply chain quality
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Supplier qualification, PPAP execution, test method validation, audit management, cross-functional collaboration, statistical analysis, regulatory compliance (FDA/ISO)
Preferred skills
ASQ certification (CQE/CSQP/CQA), Lean Six Sigma Green/Black Belt, PLM system knowledge, Minitab statistical analysis, global team management
Technologies
ASL, PPAP, IQ/OQ/PQ, FDA QSR, ISO 13485, Agile MAP PLM, Minitab
Responsibilities
Qualify suppliers and manage Approved Supplier List (ASL), Lead PPAP execution and release deliverables, Define receiving inspection requirements and validate test methods, Conduct supplier audits, Collaborate on product acceptance sampling strategies, Provide technical assistance during product/process qualification
Seniority
Senior, hands-on IC