Senior Engineer Supplier Development Quality
Core
Ensuring supplier quality for medical device components through selection, evaluation, material qualification, and regulatory compliance.
Role type
Senior Supplier Development Quality Engineer
Builds
Qualified supplier components and validated inspection procedures for heart failure medical devices
Domain
Medical Devices / Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Supplier selection and evaluation, Material qualification, Root cause analysis, FDA/GMP/ISO 13485/ISO 14971 compliance, Statistical analysis, Gage R&R studies, Process optimization, Cross-functional project leadership, Technical audits
Preferred skills
Six Sigma, Lean Manufacturing, Supervisory experience, Advanced statistical/data analysis, ASQ CQE certification
Technologies
Gage R&R, Six Sigma, Lean Manufacturing
Responsibilities
Develop and maintain supplier quality program policies and procedures, Manage Non-Conforming Material Reports and lead root cause investigations, Provide engineering guidance on inspection procedures and first article requirements, Conduct supplier capability assessments and quality system audits, Generate and monitor qualification test protocols, Lead cross-functional projects for supplier improvements
Seniority
Senior, hands-on IC with leadership responsibilities