Quality Assurance Lead

CooperVision; Madrid; Presencial; EUR 70.000 - 100.000; Jornada completa

Descripción de la vacante

CooperVision, Madrid Distribution Centre, is seeking a Quality Assurance Lead to ensure consistent quality across all operations. You will drive QMS alignment with ISO 13485, oversee regulatory compliance, and manage supplier qualifications and CAPA processes.

The role requires about 5 years in QA within medical devices or pharma, with strong knowledge of EU MDR 2017/745 and ISO 13485, and a track record in audits and change controls.

Formación

• Around 5 years of QA experience in medical devices or pharmaceutical industries.
• Experience with local and international regulations including risk management.
• Familiarity with EU MDR 2017/745 and ISO 13485 requirements.

Responsabilidades

• QMS management and maintenance in line with ISO 13485 alignments.
• Ensure regulatory compliance with EU MDR 2017/745 and ISO 13485 for distributors.
• Develop and maintain internal audit schedule and CAPA management.
• Qualify and approve suppliers, logistics providers, and service providers.
• Oversee customer complaint handling, product traceability, storage controls, and recalls readiness.
• Train employees on quality procedures and manage quality-related change controls.

Conocimientos

Quality Assurance

Regulatory Compliance

Risk Management

Descripción del empleo

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 global 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.

At CooperVision, our effort to improve lives begins with our employees. We are committed to developing people as a key global differentiator and our most important asset. We empower employees to succeed, rewarding great thinking and hard work with competitive pay, comprehensive benefits, and with a special focus on wellness. Our commitment to our core values and an employee-centric culture fuel a deeply engaged, high performing organization.

CooperVision employees pride themselves on being proactive, innovative, flexible and friendly. That's a strong reflection of our corporate culture—and part of the reason CooperVision may be a great workplace for you.