Device Quality & Compliance Engineer

Eurofins; Cambridge; On-site; GBP 60,000 - 76,000; Full time

Benefits offered by this job

Health insurance

Life Assurance

Company Pension

Employee Assistance Programme

On-site parking

Perkbox access

Job summary

Eurofins is recruiting a Medical Device Quality Compliance Engineer for a role based at a client facility in Cambridge. The position focuses on design control, risk management, and regulatory compliance for medical devices and drug-device combinations within a fast-paced environment.

You will contribute to end-to-end product development, ensure GMP and ISO 13485 alignment, and support regulatory submissions and audits.

Qualifications

• Bachelor’s, Master’s or PhD in a scientific or engineering discipline.
• Experience in regulated GxP environments with ISO 13485, ISO 14971 and related requirements.
• Proven expertise in design controls, risk management and lifecycle compliance for medical devices.

Responsibilities

• Provide design control and risk management subject matter expertise across product lifecycles.
• Lead design history file activities and risk management processes for devices and combination products.
• Collaborate with cross-functional teams, suppliers and partners to support development and regulatory submissions.
• Perform design validation, usability engineering and change control activities.
• Investigate technical and manufacturing issues, support complaint investigations and continuous improvement.
• Communicate effectively with stakeholders and support audit readiness.

Skills

Design controls

Risk management

Medical devices

GxP regulations

Cross-functional collaboration

Data analysis

Design history file

Regulatory submissions

Education

BSc/MSc/PhD in science or engineering

Pharma/medical device industry experience

Tools

MS Office

Regulatory documentation tools

Job description

Eurofins is recruiting a Medical Device Quality Compliance Engineer for a role based at a client facility in Cambridge. The position focuses on design control, risk management, and regulatory compliance for medical devices and drug-device combinations within a fast-paced environment.

You will contribute to end-to-end product development, ensure GMP and ISO 13485 alignment, and support regulatory submissions and audits.