Supply Chain Quality Specialist

2 weeks ago

Cork, Cork, Ireland beBeeSupplier Full time €60,000 - €90,000

Job Summary: We are seeking a highly motivated and experienced professional to lead supplier engagement related to barcode readiness, ensuring compliance with medical device regulations (MDR) durability and traceability criteria.

The successful candidate will be responsible for reviewing and approving supplier process performance approval plans (PPAPs), barcode validation evidence, and change notifications. They will also ensure that supplier marking systems meet MDR standards, coordinate the resolution of nonconformities, and maintain supplier audit trails and risk-based documentation for MDR compliance.

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 nonconforming products (NCs), change control, and inventory disposition workflows.
  • Closely collaborate with manufacturing engineering/quality engineering teams to ensure supplier deliverables align with internal barcode standards and milestones.

Required Skills & Tools:

  • Systems: product lifecycle management (PLM), trackwise, supplier life cycle management system (SLMS), global item management (GIM)
  • Process: PPAP, supplier readiness, NC/corrective action preventive action (CAPA), barcode traceability, supplier audit response
  • Standards: EU MDR, ISO 13485, unique device identification (UDI) supplier integration

Preferred Experience:

  • MDR/UDI supplier implementation projects
  • Interaction with base business and divisional purchasing/quality assurance
  • Barcode equipment readiness and supplier audits

This role requires a strong understanding of quality management systems, excellent communication skills, and the ability to work effectively in a fast-paced environment.

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