• Industria Farmacéutica
  • Southampton, Reino Unido
  • Contrato
    • Indefinido
    • Jornada completa
    • Salario bruto fijo no especificado
  • 103 inscritos
Descripción de la oferta
Our client, it is an European manufacturer of Healthcare devices, that combine the complexities of design with advanced high-precision technology. We are looking for a Quality Assurance Manager. The selected candidate?s main responsibilities will be:
- To guarantee the control and follow through systems to ensure the customers are receiving product to the agreed quality standards (ISO 13485:2016, MDD 93/42 and new MDR).
- To maintain the QMS active across organisation which includes risk and changes management and validations plan.
- To monitor critical suppliers, quality objectives, KPIs, incoming inspections and audit process.
- To promote the continuous improvement and management of nonconformances, complaints and corrective and preventative actions.
- To release of product batches
- To collaborate with QARA Group Director in compiling Technical Files based on Design History Files.
Estudios mínimos
- Degree in Sciences and/or Quality Systems.
Experiencia mínima
Requirements:
- Deep knowledge of ISO 13485 (2016 preferred), MDD 93/42 Medical Devices Directive and new MDR Medical Device Regulation.
- Minimum 3 years? experience working within a Quality Management System role to and applicable standard.
- Minimum 3 years? experience working in a regulated industry e.g Medical Device, Pharmaceutical or Food Industry.
Idiomas mínimos
- English mother tongue or bilingual.
- Knowledge of Spanish.