Quality Compliance Engineer

Eurofins Uk Pss; Cambourne; On-site; GBP 55,000 - 90,000; Full time

Benefits offered by this job

Health plan

Life Assurance

Company pension

Perkbox access

On-site parking

Volunteer days

Job summary

Eurofins PSS UK is seeking a Medical Device Quality Compliance Engineer in Cambridge to drive design controls and risk management across development programs, ensuring lifecycle compliance and regulatory readiness.

You will collaborate with cross-functional teams and suppliers to deliver safe, effective, patient-focused healthcare products while supporting continuous improvement and audit activities.

Qualifications

• BSc, MSc or PhD in a scientific or engineering discipline with experience in pharmaceutical/medical device industry.
• Experience in regulated GxP environments and ISO 13485, ISO 14971, 21 CFR 820/4, EU MDR.

Responsibilities

• Provide design control and risk management expertise across product lifecycle.
• Lead design history file activities and risk management processes.
• Guide cross-functional teams in product development and lifecycle compliance.
• Support regulatory submissions, audits and continuous improvement.

Skills

Design controls

Risk management

Human factors engineering

Usability engineering

Education

BSc/MSc/PhD in a scientific or engineering discipline

Job description

Job Description

We are currently recruiting for an enthusiastic and innovative Medical Device Quality Compliance Engineer. This is an exciting opportunity based at our client’s facility, a world class Pharmaceutical company based in Cambridge. This role provides a unique opportunity to support the development of innovative drug delivery devices from conception through to commercialisation while working within a multidisciplinary and innovative environment.

Unfortunately, we are unable to offer visa sponsorship for this role. This is a full time, permanent position, working a flexible 37 hour week, Monday – Friday.

As a Device Quality Compliance Engineer, you will be responsible for providing design control and risk management subject matter expertise to medical device and combination product development programmes throughout the product lifecycle. This will involve generation and review of design history file and risk management file components whilst interacting with cross functional development teams at all levels of the Client’s organisation.

Job Responsibilities that you be covering:

• You will hold a degree in a relevant scientific, engineering or life sciences discipline, with strong knowledge of design controls, risk management, combination products and applicable pharmaceutical, medical device and GMP regulations.
• You will have proven experience leading design history file activities, risk management processes and product development programmes, with the ability to ensure compliance throughout the lifecycle of combination products and medical devices.
• You will have strong technical expertise in design validation, human factors engineering, usability assessments and design change control, supporting the development of safe, effective and patient-focused healthcare products.
• You will have experience collaborating with cross-functional teams, suppliers, contractors and external partners, providing technical leadership, mentorship and guidance to support successful product development and commercialisation.
• You will have excellent analytical, problem-solving and data evaluation skills, with the ability to investigate technical, design and manufacturing issues, contribute to complaint investigations and implement effective continuous improvement initiatives.
• You will have excellent communication and stakeholder management skills, alongside a passion for innovation, quality and client service, with the ability to thrive in a fast-paced environment while supporting regulatory submissions, audit readiness and compliance activities.

Qualifications

What skills, qualifications and experiences you will hold as an Quality Compliance Engineer:

• You will hold a BSc, MSc or PhD in a scientific or engineering discipline such as Chemistry, Biology, Biomedical Sciences, Mechanical Engineering, Materials Science, Chemical Engineering or a related subject, with relevant experience within the pharmaceutical combination product and/or medical device industry.
• You will have proven experience working within regulated GxP environments, with a strong understanding of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, EU MDR requirements and their application to compliant product development and lifecycle management.
• You will have demonstrable expertise in design controls, risk management and combination product development, with the ability to identify, assess, mitigate and communicate risks while ensuring compliance throughout the product lifecycle.
• You will have knowledge of human factors engineering, usability engineering, device assembly and manufacturing processes, supported by strong analytical skills, experience troubleshooting medical device issues and the ability to perform complex data analysis to support informed decision-making.
• You will have excellent communication, documentation and stakeholder management skills, with the ability to build strong relationships with internal colleagues and external partners, work effectively with electronic systems including MS Office and provide technical leadership within cross-functional teams.
• You will have a proactive and adaptable approach, with the ability to learn new processes quickly, manage changing priorities, work independently and collaboratively, and demonstrate a passion for quality, customer service and continuous improvement within a fast-paced environment.

Additional Information

At Eurofins we are growing, innovating and always learning. We celebrate the achievements of our employees through annual long service awards, recognise our colleagues special life events, and we are committed to charitable causes through global fundraising activities.

As a Eurofins employee you will benefit from:

• Being part of a Reward and Recognition Scheme, recognising great work across our teams.
• Holiday entitlement increases with service.
• The option to opt into our Health Cash Plan, designed to help look after your everyday health and wellbeing. This allows you to claim back the cost of routine healthcare expenses such as dental check-ups, eye tests, glasses or contact lenses and other everyday medical treatments.
• Life Assurance from day one, providing cover of four times your annual salary.
• Automatic enrolment into our Company Pension Plan after three months (with the flexibility to opt out if you choose)
• Access to our Employee Assistance Programme, offering 24/7 confidential support for both personal and work-related matters.
• Being able to register your interest in volunteering days, which are designed to support employees who wish to do voluntary work during working hours as part of a wider strategy to contribute positively to the local community.
• Free on-site car parking.
• The opportunity to explore worldwide opportunities.
• Everyone who joins our team also gets access to Perkbox, allowing you to save money all year round. Whether its supermarket savings or days out, the daily coffee or a summer holiday – there’s something to suit everyone’s lifestyle.

What Happens Next

Our people are the backbone of what we do, so it's incredibly important we find the right individuals to join us. As a potential new recruit you'll be invited to meet the team in the form of an assessment centre or a staged interview process dependent on the role and it's requirements, this will give you the opportunity to see what working for Eurofins is really like and enable us to get you know your key skills and strengths.

Your data

As part of any recruitment process, the company collects and processes personal data relating to job applicants. The company is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations.

We embrace diversity! Eurofins network of companies believe in strength and innovation through diversity, being an Equal Opportunity Employer. We prohibit discrimination against employees or applications based on gender identity and/or expression, race, nationality, age, religion, sexual orientation, disability, and everything else that makes employees of Eurofins companies unique.

For more information about Eurofins PSS visit our website and watch a message below from our Global Head, Beth Di Paolo.