Quality Assurance Lead

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

This role oversees the development implementation and continuous improvement of quality systems processes and programmes driving the effective governance maintenance and ongoing enhancement of the sites Quality Management System (QMS).

• 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)

• 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

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