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- Tasks: Lead design control and risk management for medical devices and combination products.
- Company: Leading pharmaceutical R&D company in the Cambridge area.
- Benefits: Hybrid work model, competitive salary, and valuable industry experience.
- Why this job: Make a real impact in healthcare by ensuring product quality and compliance.
- Qualifications: Degree in science or engineering; experience in medical devices preferred.
- Other info: 12-month contract with opportunities for professional growth.
The predicted salary is between 36000 - 60000 £ per year.
We are looking for a Quality Engineer – Compliance to support medical device and combination product development programmes within a leading pharmaceutical R&D environment.
Key Responsibilities
- Lead and support design control and risk management activities across device and combination product programmes.
- Prepare and review Design History File (DHF) and risk management documentation.
- Ensure compliance with quality systems and regulatory standards.
- Support design validation activities, including human factors / usability engineering.
- Assist with regulatory submissions, supplier assessments, and quality audits.
- Support investigations related to clinical and commercial device manufacturing.
Requirements
- Degree in a relevant science or engineering discipline.
- Experience in medical devices, combination products, pharma, or biotech.
- Knowledge of design controls and risk management.
- Familiarity with ISO 13485, ISO 14971, 21 CFR 820, 21 CFR Part 4, and EU MDR.
- Understanding of GMP and device development processes is beneficial.
If you have experience working in regulated device or combination product environments and are interested in a hybrid contract role in the Cambridge area, please apply or get in touch.
Quality Engineer in Cambridge employer: Cpl Life Sciences
Contact Detail:
Cpl Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Engineer in Cambridge
✨Tip Number 1
Network like a pro! Reach out to professionals in the medical device and pharma sectors on LinkedIn. Join relevant groups and engage in discussions to get your name out there.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ISO standards and design controls. We recommend practising common interview questions related to compliance and risk management to show you're the right fit.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. Use our website to find roles that excite you and match your skills in quality engineering.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can set you apart from other candidates. It shows your enthusiasm and keeps you fresh in their minds.
We think you need these skills to ace Quality Engineer in Cambridge
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality Engineer role. Highlight your experience in medical devices and compliance, and don’t forget to mention any relevant projects or achievements that align with the job description.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about quality engineering in the medical device field. Mention specific skills that match the requirements, like your knowledge of ISO standards or risk management.
Showcase Relevant Experience: When filling out your application, be sure to showcase your experience with design controls and regulatory submissions. We want to see how your background fits into our world of compliance and quality assurance.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy!
How to prepare for a job interview at Cpl Life Sciences
✨Know Your Regulations
Familiarise yourself with ISO 13485, ISO 14971, and the relevant CFRs before your interview. Being able to discuss these standards confidently will show that you understand the compliance landscape in medical devices.
✨Showcase Your Experience
Prepare specific examples from your past work that highlight your experience with design controls and risk management. Use the STAR method (Situation, Task, Action, Result) to structure your answers effectively.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's approach to quality assurance and regulatory compliance. This not only shows your interest but also helps you gauge if the company aligns with your values and career goals.
✨Demonstrate Team Collaboration
Quality engineering often involves working with cross-functional teams. Be ready to discuss how you've successfully collaborated with others in the past, especially in regulated environments, to achieve project goals.