Supplier Quality Engineer (SQE)

Work Flexibility: Hybrid

18 Month FTC

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:

Travel Percentage: 10%

Supplier Quality Engineer