Supplier Quality Engineer
Supplier Quality Engineer
Posted on :
02-09-2025
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1 Vacancy
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Job Description
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
Employment Type
Full-Time
Key Skills
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