Ingeniero Principal de Calidad de Proveedores

About the role

The Supplier Quality team at Cardinal Health ensures that all products and services meet strict regulatory and quality standards. As a Senior Supplier Quality Engineer you will lead supplier qualification, monitoring and continuous improvement activities for medical devices and pharmaceutical products.

Key responsibilities

• Lead supplier qualification, evaluation and ongoing monitoring to guarantee compliance with GMP, ISO 13485, EU‑MDR and FDA requirements.
• Plan, conduct and follow‑up 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 (APQP, PFMEA, control plans, GRR, FAI, IQ/OQ/PQ, PPA) in collaboration with Procurement, Manufacturing and R&D.
• Analyze quality trends, metrics and risk indicators to identify improvement opportunities.
• Partner with cross‑functional teams (Engineering, Operations, Regulatory Affairs) to ensure product and process quality objectives are met.

Required profile

• 4‑8 years of experience in supplier quality for medical devices or pharmaceuticals.
• Bachelor’s degree in a related field or equivalent work experience.
• Advanced English proficiency (spoken and written).
• Strong knowledge of supplier qualification processes, audits, root‑cause analysis and CAPA systems.

Required skills

• Supplier qualification and audit expertise
• CAPA management and root‑cause analysis
• Quality Management Systems (ISO 13485, ISO 14971)
• Regulatory knowledge: EU‑MDR, FDA, cGMP
• APQP tools: PFMEA, control plan, GRR, FAI, IQ/OQ/PQ, PPA
• Risk management and compliance reporting