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Senior Supplier Quality Engineer

Cardinal Health · Alajuela

New
Senior 🇬🇧 English
MDD EU-MDR ISO 13485 FDA cGMP ISO 14971 CAPA PFMEA control plan GRR FAI IQ/OQ/PQ PPA

Job description

About the role

Cardinal Health is seeking a Senior Supplier Quality Engineer to lead supplier qualification, monitoring and continuous improvement activities across the product lifecycle, ensuring compliance with medical device and pharmaceutical regulations.

Key responsibilities

  • Lead supplier qualification, evaluation and monitoring to maintain compliance with GMP, ISO 13485, EU‑MDR and FDA requirements.
  • Plan, conduct and follow‑up on supplier audits, assessments and corrective actions (CAPA, NCRs, complaints).
  • Review and approve supplier quality documentation, change notifications and quality agreements.
  • Investigate supplier‑related quality issues, perform root‑cause analysis and drive timely resolution.
  • Support New Product Development projects with APQP deliverables such as PFMEA, control plans, GRR, FAI, IQ/OQ/PQ and PPA.
  • Analyze supplier quality trends, metrics and risk indicators to identify improvement opportunities.

Required profile

  • 4‑8 years of experience in supplier quality or related roles within regulated environments.
  • Bachelor’s degree in a relevant field or equivalent work experience.
  • Advanced English communication skills (spoken and written).
  • Strong analytical, communication and stakeholder‑management abilities.

Required skills

  • Knowledge of MDD, EU‑MDR, ISO 13485, FDA, cGMP and ISO 14971.
  • Experience with CAPA systems, root‑cause analysis and supplier audits.
  • Familiarity with APQP tools: PFMEA, control plan, GRR, FAI, IQ/OQ/PQ, PPA.

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Published 1 day ago

Expires 1 month from now

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Cardinal Health

Alajuela