New Product Development Senior Supplier Quality Engineer
Core
Senior Supplier Quality Engineer ensuring design transfer and manufacturability for new medical device products by managing supplier selection, qualification, and process validation.
Role type
Senior IC supplier quality engineer (medical devices)
Builds
New medical device products and their manufacturing supply chain
Domain
Medical technology / Surgical devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Supplier selection and qualification, Process validation (PPAP, IQ/OQ/PQ), FMEA, Root cause analysis, Project management, Statistical analysis, Design for Manufacturability (DFM), Regulatory compliance knowledge
Preferred skills
CQE certification, Six Sigma Green Belt, Lead auditor experience, FDA regulations knowledge, ISO 13485 knowledge, SAP/Trackwise/Windchill proficiency
Technologies
SAP, Trackwise, Windchill
Responsibilities
Manage supplier selection, qualification, and performance improvement; Oversee process validation and Design Transfer; Analyze manufacturing data and manage Non-Conformance Reports; Collaborate on Design Failure Mode and Effects Analysis (DFMEA)
Seniority
Senior, hands-on IC
