Experteer Overview
As Quality Assurance Lead at CooperVision Madrid Distribution Centre, you will drive the quality management framework across distribution operations. You will maintain and continuously improve an ISO 13485-aligned QMS, ensuring compliance and readiness for certification. You will lead audits, CAPA, supplier qualification, and risk management to safeguard product quality and regulatory conformance. This role partners with cross-functional teams to sustain traceability, storage controls, and recall procedures, delivering measurable quality improvements.

Compensaciones / Ventajas
• Maintain and continuously improve the QMS aligned to ISO 13485
• Ensure procedures, forms and work instructions are current and controlled
• Oversee internal audit program and regulatory compliance activities
• Manage non-conformances, CAPA, and corrective actions across product, process, and QMS
• Qualify and approve suppliers, logistics providers, and service providers
• Oversee customer complaint handling and product traceability




• Ensure appropriate storage conditions and environmental controls
• Lead risk management activities and risk-based decision making
• Manage quality-related change controls and recall/field safety actions
• Support certification readiness for ISO 13485 and regulatory audits

Responsabilidades
• ~5 years of Quality Assurance experience in Medical Device manufacturing or pharma
• Experience with local and international regulations including EU MDR 2017/745 and ISO 13485
• Proven experience with risk management principles and QMS governance
• Strong CAPA, non-conformance handling and supplier qualification experience
• Ability to lead audits and ensure regulatory compliance across distribution
• Knowledge of product traceability, storage and environmental controls
• Experience in training employees on quality procedures

Requisitos principales
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📌 Quality Assurance Lead (Madrid)
🏢 The Cooper Companies
📍 Madrid