Senior Supplier Quality Engineer – Medical Devices

We are seeking a Senior Supplier Quality Engineer to support supplier qualification, new product introduction, and ongoing supplier quality activities for our medical device client. This role partners with suppliers and cross-functional teams to ensure purchased parts, materials, and services meet quality and performance requirements. Key Responsibilities Lead supplier and part qualification activities, including Production Part Approval Process (PPAP) submissions. Review supplier qualification deliverables, including control plans, PFMEA, IQ/OQ/PQ documentation, process capability studies, and first article inspections. Collaborate with suppliers, incoming inspection, and metrology teams to develop inspection methods, validate test methods, and establish acceptance sampling plans. Support new product introduction (NPI) projects by ensuring supplier readiness and completion of required quality deliverables. Maintain Approved Supplier List (ASL) records, including supplier classifications, selection documentation, agreements, and audit records. Prepare, review, and approve change orders in accordance with quality system requirements. Investigate and disposition nonconforming materials, working with suppliers and internal teams to resolve quality issues. Assess supplier processes and performance, provide feedback, and support improvement activities. Collaborate with Engineering, Manufacturing, Quality, and Supply Chain to achieve project and supplier quality objectives. Required Qualifications Bachelor’s degree and at least 4 years of relevant experience, or an advanced degree and at least 2 years of relevant experience. Experience in supplier quality engineering within the medical device industry. Hands-on experience with PPAP and associated qualification deliverables, including control plans, PFMEA, process qualification, process capability studies, and first article inspections. Experience developing inspection methods, validating test methods, and establishing acceptance sampling plans. Knowledge of medical device quality system requirements. Strong problem-solving, technical documentation, communication, and cross-functional collaboration skills. Ability to manage assigned projects independently and coordinate deliverables with suppliers and internal stakeholders. Preferred Qualifications Experience supporting supplier quality activities for new product introductions. Familiarity with approved supplier list management, supplier assessments, and change control. Experience partnering with incoming inspection and metrology teams.

View the full posting and apply