Quality Engineer II
Core
Partner with suppliers and cross-functional teams to ensure delivery of high-quality, compliant components through PPAP approvals, SCR lifecycle management, and supplier performance monitoring. (via careerplan.io/jobs/R64963-2-quality-engineer-ii-at-medtronic)
Role type
Quality Engineer II (Supplier Quality)
Builds
High-quality, compliant medical device components and materials
Domain
Medical device manufacturing / Supplier Quality Management
Required skills
Supplier management, PPAP execution, SCR lifecycle management, Corrective and Preventive Action (CAPA), Supplier audits, PFMEA, MSA, Control Plans, Receiving inspection planning, Test method validation
Preferred skills
FDA Quality System Regulation knowledge, ISO 13485 standard knowledge, Lean Six Sigma Yellow/Green Belt, CQE/CQA certification, Global team collaboration experience
Technologies
PPAP, SCR, PFMEA, MSA, Control Plans
Responsibilities
Manage Supplier Corrective and Preventive Action plans, Execute supplier audits and ASL management, Develop product acceptance sampling strategies, Support Pre-Market Quality Engineering for New Product Development, Validate internal test methods, Monitor supplier performance for continuous improvement
Seniority
Mid-Senior, hands-on IC
