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 site's Quality Management System (QMS).
QMS Management and Maintenance: Maintain and continuously improve the ISO *-aligned QMS.
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Ensure all quality procedures, policies, forms, and work instructions are controlled and up to date.Regulatory Compliance with applicable regulationsEU MDR **ISO * requirements relevant to distributorsDevelop 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 ControlsStorage 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 controlsMaintain recall and field safety corrective action procedures.KPI and Quality ReportingCertification Readiness (ISO * 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 * - ISO ***#LI-JL1

📌 Ai Quality Assurance Lead For Ml (España)
🏢 Abbvie
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