Supplier Quality Engineer

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