Supplier Quality Engineer

Role and Responsibilities:

4+ years of experience in Supplier Quality Engineering, Quality Assurance, Manufacturing Quality, or Medical Device Quality Systems.Manage a high volume of supplier quality activities and requests, ensuring effective prioritization, organization, and timely execution of deliverables. Review supplier documentation, technical files, certifications, validation records, and objective evidence to ensure compliance, completeness, traceability, and alignment with product and regulatory requirements. Perform BOM compliance screening and material/component compliance assessments to support product quality and regulatory compliance. Support Approved Supplier List (ASL) management, supplier qualification, onboarding, performance monitoring, and supplier governance activities. Track, coordinate, and drive closure of Supplier Corrective Action Requests (SCARs), supplier quality actions, deviations, and continuous improvement initiatives. Verify supplier compliance with contractual, quality, and regulatory requirements through requirements flow-down reviews, objective evidence assessment, and risk-based evaluations. Reconcile supplier evidence with product requirements, design inputs, specifications, verification records, and risk management documentation to ensure appropriate traceability. Review supplier change notifications and perform impact assessments in collaboration with Quality, Regulatory, R&D, Manufacturing, and Supply Chain stakeholders. Support supplier audits, audit readiness activities, evidence collection, compliance reviews, APQP execution, Quality Transition Plans, and supplier development initiatives. Build productive internal and external relationships, provide technical presentations and status updates, prepare supplier quality metrics and dashboards, and apply sound judgment to identify risks, assess impact across the value chain, and drive appropriate actions.