Supplier Quality Engineer

Stryker Group; Limerick; Hybrid; EUR 50,000 - 75,000; Full time

Job summary

Stryker Group is looking for a Supplier Quality Engineer for an 18-month FTC in a hybrid role. You will lead supplier engagements and ensure compliance with EU MDR standards while maintaining quality assurance throughout the supplier management process. Candidates with experience in medical device regulations and supplier audits are preferred for this dynamic position.

Qualifications

• Experience in MDR/UDI supplier implementation projects preferred.
• Interacts with base business and divisional purchasing/QA.
• Familiarity with barcode equipment readiness and supplier audits.

Responsibilities

• Lead supplier engagement related to barcode readiness.
• Review and approve supplier PPAPs and validation evidence.
• Coordinate resolution of non-conformances and inventory workflows.

Skills

Self-directed

Supplier-savvy

Fast-paced readiness executor

Tools

OnePLM

Trackwise

SLMS

GIM

Job description

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