Senior Quality Engineer – Medical Devices (Hybrid)

SPD Swiss Precision Diagnostics; Bedford; Hybrid; GBP 55,000 - 75,000; Full time

Benefits offered by this job

25 days paid annual leave

Pension scheme

Private Medical Insurance

Enhanced maternity and paternity pay

Health & Wellbeing programme

Life assurance

Electric car charging points

Parkland setting with transport links

Job summary

SPD Swiss Precision Diagnostics GmbH in Bedford, UK, is seeking a Senior Quality Engineer for a permanent full-time role with hybrid working. The role focuses on driving quality improvements, overseeing contract manufacturers, and supporting new product introductions and equipment transfers.

The candidate will work within an ISO 13485 and MDR/IVD regulated environment, with a strong emphasis on audits, CAPA/NC resolution, and KPI-driven performance management.

Qualifications

• Experience in quality and compliance within medical device environments.
• Strong knowledge of ISO 13485:2016 and FDA 21 CFR Part 820.
• Ability to drive quality improvements and manage KPIs.

Responsibilities

• Drive quality planning and continuous improvement across manufacturing partners.
• Oversee quality oversight of contract manufacturers, packers, and suppliers.
• Lead validation and verification activities for new product introductions and equipment transfers.
• Monitor performance via KPIs and coordinate timely NC/CAPA resolution.

Skills

Quality Engineering

Regulatory Compliance

Auditing

Job description

SPD Swiss Precision Diagnostics GmbH in Bedford, UK, is seeking a Senior Quality Engineer for a permanent full-time role with hybrid working. The role focuses on driving quality improvements, overseeing contract manufacturers, and supporting new product introductions and equipment transfers.

The candidate will work within an ISO 13485 and MDR/IVD regulated environment, with a strong emphasis on audits, CAPA/NC resolution, and KPI-driven performance management.