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 suppliersQuality Engineering (QE) – for PPAP/FAI review, risk assessments, and issue escalationRegulatory Affairs – for MDR-related documentation checks and supplier traceabilitySupply Chain / Planning – for coordination on supplier schedules, PO releases, and material dispositionOperations / Receiving Inspection – to confirm readiness to inspect and verify barcode compliance at incomingProject Management (PMO) – to align timelines, flag risks, and manage cross-functional handoffsIT / Supplier Portals – where applicable, for document submission or traceability in supplier systemsDivisional SQ / Base Business Teams – for supplier escalation paths, audit preparation, and governance reviews

Required Skills & Tools:

Systems: OnePLM, Trackwise, SLMS, GIMProcess: PPAP, supplier readiness, NC/CAPA, barcode traceability, supplier audit responseStandards: EU MDR, ISO 13485, UDI supplier integrationCompetencies: Self-directed, supplier-savvy, able to manage external/internal alignment, fast-paced readiness executor

Preferred Experience:

MDR/UDI supplier implementation projectsInteraction with base business and divisional purchasing/QABarcode equipment readiness and supplier audits

Travel Percentage: None