Quality Assurance

Oferta de trabajo sector Industria Farmacéutica - referencia 16425

Cerrada
Oferta de trabajo sector
Sector: Industria Farmacéutica
País: Reino Unido
Población: Southampton
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1
Inscritos
103
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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.
Contrato
Tipo de contrato: Indefinido
Jornada laboral: Jornada completa
Salario bruto fijo: No especificado
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