Quality Assurance Lead - Madrid Distribution (ISO 13485)

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

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.