Senior Supplier Quality Engineer
Cardinal Health · Alajuela
Description du poste
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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Cardinal Health
Alajuela