Sr. Supplier Quality Engineer
Core
Sr. Supplier Quality Engineer responsible for supplier selection, evaluation, material qualification, and receiving inspection for structural heart devices.
Role type
Senior IC supplier quality engineer (medical devices)
Builds
Qualified supplier base and compliant supplied components for structural heart products
Domain
Medical devices / Structural Heart
Required skills
supplier quality engineering, FDA regulations, GMP, ISO 13485, ISO 14971, SAP, Six Sigma, Lean Manufacturing, statistical analysis, Gage R&R, engineering analysis, project management
Preferred skills
ASQ CQE certification, ISO 13485 auditing, cross-divisional business model experience, matrixed environment adaptability
Technologies
SAP
Responsibilities
Develop and maintain supplier quality program policies and procedures; review and approve supplied product drawings and quality plans; manage development of inspection procedures and first article requirements; assess supplier capabilities via audits and technical discussions; lead Non-Conforming Material Reviews; conduct supplier performance reviews; design experiments for process optimization; apply systematic problem-solving methodologies.
Seniority
Senior, hands-on IC with supervisory/leadership experience