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Hybrid Quality Management Role
2 weeks ago
A SQE Manager role in our Hybrid workplace is available, working closely with suppliers to ensure high-quality products.
Key Responsibilities:
- Engage suppliers for barcode readiness and lead kickoff meetings.
- Review and approve supplier PPAPs, validation evidence, and change notifications.
- Evaluate supplier marking systems for MDR compliance.
- Collaborate on NCs, change control, and inventory disposition workflows.
- Maintain supplier audit trail and risk-based documentation.
Collaborates With:
- Manufacturing Engineering for technical specs and equipment readiness.
- Quality Engineering for PPAP/FAI review and risk assessments.
- Regulatory Affairs for MDR-related documentation checks.
- Supply Chain/Planning for coordination on supplier schedules and material disposition.
- Operations/Receiving Inspection for incoming inspection readiness.
- Project Management (PMO) for timeline alignment and cross-functional handoffs.
Required Skills & Tools:
- Systems: OnePLM, Trackwise, SLMS, GIM.
- Process: PPAP, supplier readiness, NC/CAPA, barcode traceability.
- Standards: EU MDR, ISO 13485, UDI supplier integration.
Preferred Experience:
- MDR/UDI supplier implementation projects.
- Interaction with base business and divisional purchasing/QA.
