Supplier Quality Engineer
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Job Location:
Monthly Salary:
Posted on:
02-09-2025
Vacancies:
1 Vacancy
Job Summary
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
Key Skills
- Project / Program Management
- Change Management
- Succession Planning
- Procurement
- Program Management
- ISO 9001
- Lean Six Sigma
- Quality Systems
- Quality Management
- Supplier Management
- HACCP
- As9100
About Company
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more
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