Job DescriptionThe Quality Assurance Lead for the CooperVision Madrid Distribution Centre is responsible for ensuring the consistent delivery of quality standards across all operations.

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Job DescriptionThe Quality Assurance Lead for the CooperVision Madrid Distribution Centre is responsible for ensuring the consistent delivery of quality standards across all operations.
Responsibilities
- QMS Management and Maintenance: Maintain and continuously improve the ISO 13485-aligned QMS.. Ensure all quality procedures, policies, forms, and work instructions are controlled and up to date.
- Regulatory Compliance with applicable regulations
- EU MDR 2017/745
- ISO 13485 requirements relevant to distributors
- Develop and maintain an annual internal audit schedule.
- Non-Conformance and CAPA Management. Manage product, process, and QMS non-conformities.
- Qualify and approve suppliers, logistics providers, and service providers.




- Oversee customer complaint management processes
- Product Traceability and Distribution Controls
- Storage and Environmental Control. Ensure storage conditions meet requirements.
- Ensure employees are trained on quality procedures.
- Risk Management. Identify quality and compliance risks within the distribution process.
- Manage quality-related change controls
- Maintain recall and field safety corrective action procedures.
- KPI and Quality Reporting
- Certification Readiness (ISO 13485 Certification)

Qualifications
- Around 5 years’ experience in Quality Assurance either in Medical Device manufacturing or Pharma industry.
- Proven experience working with local and international regulations including Risk Management principles:
- EU MDR 2017 /745
- ISO 13485

About UsCooperVision is a general leader in the contact lens industry, dedicated to helping improve the way people see every day. Achieving that goal takes

📌 Quality Assurance Lead (Madrid)
🏢 Coopervision
📍 Madrid