Supplier Quality Engineer
Core
Evaluates quality and process controls of medical device suppliers to ensure compliance with Merit, customer, and industry standards.
Role type
Supplier Quality Engineer
Builds
Sustainable supplier quality systems and compliance for medical device manufacturing
Domain
Medical devices / Manufacturing Quality
Deliverable
client delivery
Required skills
Supplier quality management, Risk management (ISO 14971), Quality Engineering, Statistical analysis, Project scheduling, Lean Manufacturing, Technical problem solving, Data analysis
Preferred skills
FDA regulated environment experience, Medical instrumentation (GMPs, ISO13485), Supplier/part management, ASQ Certified Quality Engineer, ASQ Quality Auditor
Technologies
Spreadsheets, Database software, Word processing tools
Responsibilities
Maintain supplier quality performance metrics and requirements; Coordinate documentation updates for supplied products; Manage supplier selection, approval, and performance evaluation; Conduct on-site supplier audits and evaluate performance; Resolve supplier performance issues via Corrective Action Requests; Review supplier systems for quality gaps; Facilitate supplier change notification processes; Present supplier performance metrics and risk updates to management.
Seniority
Mid-level, hands-on IC
