MedTech Quality Compliance Engineer – Device Assurance

SmartRecruiters, Inc.; Cambridge; On-site; GBP 45,000 - 65,000; Full time

Benefits offered by this job

Reward and Recognition Scheme

Health Cash Plan

Life Assurance

Job summary

Eurofins Scientific is recruiting a Medical Device Quality Compliance Engineer for a full-time, permanent role based at a client facility in Cambridge. You will provide design control and risk management expertise across pharmaceutical and medical device programs, supporting compliance throughout product lifecycles.

The role requires strong knowledge of GMP regulations and ISO standards, with cross-functional collaboration to drive safe, effective healthcare products.

Qualifications

• Degree in a scientific or engineering field with pharma/medical device experience.
• Experience in ISO 13485, ISO 14971, 21 CFR 820/4, EU MDR.
• Led design history file activities and risk management.
• Strong data analysis and problem-solving.
• Excellent communication with cross-functional teams.

Responsibilities

• Provide design control and risk management subject matter expertise across product lifecycles.
• Generate and review design history file and risk management file components.
• Collaborate with cross-functional development teams and external partners.
• Support regulatory submissions, audit readiness and compliance activities.
• Investigate issues with data-driven root cause analysis and continuous improvement.

Skills

Design controls

Risk management

GxP environments

Regulatory submissions

Quality assurance

Education

BSc/MSc/PhD in science or engineering

Tools

MS Office

Job description

Eurofins Scientific is recruiting a Medical Device Quality Compliance Engineer for a full-time, permanent role based at a client facility in Cambridge. You will provide design control and risk management expertise across pharmaceutical and medical device programs, supporting compliance throughout product lifecycles.

The role requires strong knowledge of GMP regulations and ISO standards, with cross-functional collaboration to drive safe, effective healthcare products.