Quality Assurance Specialist

2 weeks ago

Cork, Cork, Ireland beBeeSupplier Full time €93,600 - €99,600
Job Overview:

This is a critical role in ensuring supplier quality and compliance with regulatory requirements. The Supplier Quality Engineer will be responsible for leading supplier engagement related to barcode readiness, reviewing and approving supplier PPAPs, and ensuring that supplier marking systems meet MDR durability and traceability criteria.

The ideal candidate should have experience in MDR/UDI supplier implementation projects, interaction with base business and divisional purchasing/QA, and barcode equipment readiness and supplier audits.

  • 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.
  • Closely collaborate with Manufacturing Engineering and Quality Engineering teams to ensure supplier deliverables align with internal barcode standards and milestones.

Key Responsibilities:

  • Maintain supplier audit trail and risk-based documentation for MDR compliance.
  • Coordinate resolution of NCs, change control, and inventory disposition workflows.
Required Skills & Qualifications:
  • Systems: OnePLM, Trackwise, SLMS
  • Process: PPAP, supplier readiness, NC/CAPA, barcode traceability
  • Standards: EU MDR, ISO 13485, UDI supplier integration
  • Competencies: Self-directed, supplier-savvy, able to manage external/internal alignment, fast-paced readiness executor

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