Supplier Quality Engineer

Summary : We are seeking an experienced Supplier Quality Engineer (SQE) with a strong background in the Medical Device industry to support supplier quality, compliance, and process validation activities.Roles & Responsibilities :Ensure suppliers consistently deliver quality parts, materials, and services meeting company requirementsEvaluate and onboard suppliers into the Approved Supplier List (ASL)Review and approve PPAP documentation, Control Plans, Process Flow Charts, Capability Studies, DFMEA, and PFMEAConduct supplier risk assessments and maintain supplier risk profilesFacilitate Supplier Quality Agreements and conduct supplier auditsSupport Process Validation activities (IQ, OQ, PQ), MSA/TMV, and Control PlansCoordinate supplier evaluation and selection activities for new suppliers and process changesManage documentation within PLM systems and ensure timely approvals and releasesCollaborate with global quality teams on Supplier Data Review (SDR) and Supplier Owned Quality (SOQ) initiativesEducation & Experience :Bachelor's degree in Engineering, Technical, or Scientific discipline8+ years of Supplier Quality experience in the Medical Device industry Strong knowledge of quality systems, supplier quality processes, and regulatory requirementsExperience with PPAP, DFMEA, PFMEA, MSA, Risk Management, and Process Validation (IQ/OQ/PQ)Experience working with PLM systems and quality documentation tools