Senior Quality Engineer – Medical Devices (Hybrid)

SPD Development Company Ltd; Bedford; Híbrido; GBP 45.000 - 50.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

25 days annual leave + bank holidays

Company pension scheme

Private Medical Insurance

Enhanced maternity/paternity pay

Health and Wellbeing programme

Life assurance

Electric car charging points

Parkland setting, good transport links

Descripción de la vacante

Swiss Precision Diagnostics GmbH (SPD) in Bedford, UK, seeks Senior Quality Engineer to drive quality improvements and oversee supplier quality in a medical device environment. The role offers hybrid working, permanent full-time, and benefits.

You will ensure compliance with ISO 13485, US FDA 21 CFR Part 820, and other standards, coordinating internal and supplier audits and CAPA processes. The successful candidate will have experience in quality and compliance within medical devices, strong

Formación

• Experience in quality and compliance within a medical device environment.
• Working knowledge of ISO 13485:2016 and US FDA 21 CFR Part 820.
• Ability to drive quality improvements and coordinate audits.
• Experience with supplier audits and CAPA closure.

Responsabilidades

• Drive quality improvements through meticulous quality planning.
• Oversee contract manufacturers, packers and suppliers for performance.
• Support new product introduction and equipment transfer via validation and verification.
• Monitor KPIs and coordinate NC/CAPA resolution.
• Ensure compliance with ISO 13485 and MDR/IVDR directives as applicable.

Conocimientos

Quality management

Auditing

CAPA process

Regulatory knowledge

Stakeholder comms

Descripción del empleo

Swiss Precision Diagnostics GmbH (SPD) in Bedford, UK, seeks Senior Quality Engineer to drive quality improvements and oversee supplier quality in a medical device environment. The role offers hybrid working, permanent full-time, and benefits.

You will ensure compliance with ISO 13485, US FDA 21 CFR Part 820, and other standards, coordinating internal and supplier audits and CAPA processes. The successful candidate will have experience in quality and compliance within medical devices, strong