Job Description

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

The 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 Us

CooperVision is a general leader in the contact lens industry, dedicated to helping improve the way people see every day. Achieving that goal takes the collaboration of team members with wide-ranging skills; from scientists and researchers, to manufacturing and operations experts, to sales and marketing professionals.
A

📌 Quality Assurance Lead (Madrid)
🏢 Coopervision
📍 Madrid