Supplier Quality Engineer II.
Core
Manage strategic Contract Manufacturers (CMs) and Original Equipment Manufacturers (OEMs) to ensure finished medical device/component quality and drive process improvements.
Role type
Supplier Quality Engineer II (Individual Contributor)
Builds
Medical devices and components for patients
Domain
Healthcare technology / Medical devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Supplier qualification and auditing, root cause analysis, statistical analysis (Ppk/Cpk), regulatory compliance (ISO 13485, IEC 60601), receiving inspection strategy, product acceptance sampling, control plan development, metrology and measurement techniques
Preferred skills
Injection molding defect analysis, sterile barrier packaging validation, Six Sigma/DFSS/Lean certification, ASQ CQE/CQA/CSQP certification
Technologies
Minitab, ERP systems
Responsibilities
Ensure suppliers deliver quality parts and services; monitor parts from acquisition through manufacturing; develop and prioritize auditing schedules; evaluate supplier performance; provide Pre-Market Quality Engineering support for New Product Development; define receiving inspection requirements and test method validation.
Seniority
Mid-level Individual Contributor