Senior Supplier Quality Engineer - Medical Devices

We are seeking a Senior Supplier Quality Engineer to lead supplier qualification, product acceptance, and validation activities throughout the medical device product lifecycle. The ideal candidate brings medical device experience, an electrical or mechanical engineering background, and strong expertise in component and product qualification. Key Responsibilities Lead supplier and product qualification activities to ensure suppliers consistently deliver quality parts, materials, and services. Develop product acceptance strategies, sampling plans, control plans, and incoming inspection requirements. Lead and support test method validation, equipment qualification, and process validation activities. Evaluate process capability and work with suppliers to prevent defects and improve manufacturing performance. Manage supplier change requests and supplier-related nonconforming material reports (NCMRs), including disposition and corrective and preventive actions. Support supplier audits, performance monitoring, and Approved Supplier List activities. Partner with R&D, Component Engineering, Manufacturing, and Quality teams to support new product development and sustaining engineering. Communicate supplier performance, project progress, and quality issues to stakeholders and leadership. Qualifications Bachelor’s degree in Engineering with at least 4 years of relevant experience, or an advanced degree with at least 2 years of relevant experience. Medical device industry experience. Electrical, mechanical, or electromechanical engineering background. Hands‑on experience with component or product qualification. Experience with test method validation and equipment or process validation. Strong understanding of process capability and statistical quality methods. Familiarity with supplier quality controls, incoming inspection, change management, and corrective actions. Ability to independently manage projects, resolve complex technical issues, and collaborate across functions. Ideal Experience Approximately 3–6 years of relevant engineering experience. Supplier quality support for new product development. Experience developing acceptance sampling strategies and control plans. Experience leading supplier investigations, audits, and continuous improvement activities. #J-18808-Ljbffr ATR International