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.
•