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