Supplier Quality Engineer
Full-time
Description
Work Flexibility: Hybrid<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p><b>18 Month FTC</b></p><p></p><p><b>Role: Supplier Quality Engineer (SQE)</b></p><p><b>Location: Hybrid</b></p><p></p><p></p><p><u>Key Responsibilities:</u></p><p></p><ul><li>Lead supplier engagement related to barcode readiness, including kickoff meetings and implementation tracking.</li><li>Review and approve supplier PPAPs, barcode validation evidence, and change notifications.</li><li>Ensure supplier marking systems meet MDR durability and traceability criteria.</li><li>Coordinate resolution of NCs, change control, and inventory disposition workflows.</li><li>Collaborate closely with ME/QE teams to ensure supplier deliverables align with internal barcode standards and milestones.</li><li>Maintain supplier audit trail and risk-based documentation for MDR compliance.</li></ul><p></p><p><u>Collaborates With:</u></p><p></p><ul><li>Manufacturing Engineering (ME) – to confirm technical specs and equipment/process readiness at suppliers</li><li>Quality Engineering (QE) – for PPAP/FAI review, risk assessments, and issue escalation</li><li>Regulatory Affairs – for MDR-related documentation checks and supplier traceability</li><li>Supply Chain / Planning – for coordination on supplier schedules, PO releases, and material disposition</li><li>Operations / Receiving Inspection – to confirm readiness to inspect and verify barcode compliance at incoming</li><li>Project Management (PMO) – to align timelines, flag risks, and manage cross-functional handoffs</li><li>IT / Supplier Portals – where applicable, for document submission or traceability in supplier systems</li><li>Divisional SQ / Base Business Teams – for supplier escalation paths, audit preparation, and governance reviews</li></ul><p></p><p></p><p></p><p>Required Skills & Tools:</p><p></p><ul><li>Systems: OnePLM, Trackwise, SLMS, GIM</li><li>Process: PPAP, supplier readiness, NC/CAPA, barcode traceability, supplier audit response</li><li>Standards: EU MDR, ISO 13485, UDI supplier integration</li><li>Competencies: Self-directed, supplier-savvy, able to manage external/internal alignment, fast-paced readiness executor</li></ul><p></p><p>Preferred Experience:</p><p></p><ul><li>MDR/UDI supplier implementation projects</li><li>Interaction with base business and divisional purchasing/QA</li></ul><ul><li>Barcode equipment readiness and supplier audits</li></ul><p></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>Travel Percentage: 10%<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p></p><p></p><p></p><p></p>