Quality Compliance Engineer

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate.

Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inclusion across the entire network of Eurofins companies.

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.

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…