Experteer Overview

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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 / Beneficios

- 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 xugodme 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