Senior Supplier Quality Engineer - Direct Materials Acquisitions
Core
Ensure patient safety and improve supplier manufacturing processes for direct materials and components in the medical device industry.
Role type
Senior Supplier Quality Engineer (Direct Materials)
Builds
Supplier quality systems, corrective action plans, and compliance with regulatory standards for acquired entities.
Domain
Medical Device / Regulated Manufacturing
Required skills
Systematic problem-solving, supplier audit leadership, CAPA/SCAR management, process validation, design controls, risk management, project management, cross-functional collaboration, regulatory compliance, on-site assessment
Preferred skills
Medical device engineering experience, ISO 13485 lead auditor certification, ASQ certification (CQE, CBA, SSGB, SSBB), leadership on materials teams, drug or animal tissue experience
Technologies
PLM, ERP
Responsibilities
Evaluate and resolve supplier quality issues using systematic methodologies; manage sustaining quality issues and design change implementations; lead supplier audits for regulatory compliance; investigate complaints and manage SCARs/NCEPs; support new product development by integrating acquired suppliers into the quality system; champion internal and external regulatory audits; develop and implement quality policies and procedures.
Seniority
Senior, hands-on IC