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- Tasks: Lead quality assurance for innovative medical devices and ensure compliance with global standards.
- Company: Global biopharma organisation with a focus on cutting-edge medical technology.
- Benefits: Hybrid work model, collaborative environment, and exposure to the full product lifecycle.
- Other info: Opportunity for career growth in a dynamic and supportive setting.
- Why this job: Join a specialist team and make a real impact on life-changing products.
- Qualifications: BSc/MSc/PhD in relevant field and 2+ years in regulated medical device environments.
The predicted salary is between 40000 - 50000 £ per year.
A global biopharma organisation is growing its Devices Centre of Excellence in Cambridge, UK and is looking for a Quality Engineer (Compliance) to support medical device and drug-device combination product programmes across the product lifecycle from early development through to clinical and commercial supply. This is a hands-on, collaborative role for someone who enjoys being close to the development teams, keeping work audit-ready, and ensuring design control and risk management activities meet internal and global regulatory standards.
Key Responsibilities
- Leading design control and risk management activities for assigned programmes, ensuring deliverables are accurate, approved and maintained.
- Supporting and facilitating risk management with external design and manufacturing partners.
- Ensuring compliance with key standards and regulations including ISO 13485, ISO 14971, 21 CFR 820, EU MDR (and related internal procedures).
- Providing input into design validation activities, including Human Factors Engineering / usability assessments.
- Assessing suppliers and external partners for QMS capability, compliance and readiness.
- Supporting investigations into device issues arising from clinical trials and commercial manufacturing.
- Contributing to regulatory submission content for assigned device projects.
- Supporting internal and external audits of the DCoE Quality Management System.
We’re open on background, but you’ll likely have:
- A BSc/MSc/PhD in a relevant science or engineering discipline.
- 2+ years’ experience in medical devices and/or combination products within a regulated environment.
- Practical experience with design controls and risk management (e.g., working with DHF/RMF components, reviews, traceability, risk files).
- Exposure to Human Factors / usability engineering and device assembly/manufacturing considerations.
- Working knowledge of ISO 13485 / ISO 14971 / 21 CFR 820 / 21 CFR 4 / EU MDR and the confidence to apply them pragmatically.
- Strong attention to detail, comfort following established procedures, and the ability to manage multiple priorities with minimal supervision.
Nice to have
- Familiarity with standards such as EN 62366, EN 60601, EN 62304.
- Good understanding of GMP principles and how development work translates into clinical/commercial settings.
Why this role?
- Work on innovative combination products in a specialist Devices Centre of Excellence.
- Broad lifecycle exposure: design → validation → clinical → commercial.
- Hybrid model with meaningful on-site collaboration in Cambridge, UK.
Interested? If you’ve got solid design controls + risk management experience in device/combination products and want a role where you’ll be genuinely embedded with development teams, get in touch and I’ll share full details and context around the programme and expectations.
Quality Engineer, Compliance in Cambridge employer: Next Phase Recruitment Limited
Contact Detail:
Next Phase Recruitment Limited Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Engineer, Compliance in Cambridge
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect with professionals on LinkedIn. You never know who might have the inside scoop on job openings or can refer you directly.
✨Tip Number 2
Prepare for interviews by practising common questions related to quality engineering and compliance. Think about your past experiences and how they relate to the role. We recommend doing mock interviews with friends or using online platforms to boost your confidence.
✨Tip Number 3
Showcase your skills through projects or case studies. If you’ve worked on relevant design control or risk management activities, create a portfolio that highlights your contributions. This will give you an edge and demonstrate your hands-on experience.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in being part of our team at StudySmarter.
We think you need these skills to ace Quality Engineer, Compliance in Cambridge
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality Engineer role. Highlight your experience with design controls and risk management, and don’t forget to mention any relevant standards you’re familiar with, like ISO 13485 or EU MDR.
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 biopharma sector. Share specific examples of how you've ensured compliance in past roles.
Showcase Your Collaboration Skills: Since this role involves working closely with development teams, make sure to highlight your collaborative experiences. Talk about how you’ve facilitated teamwork in previous projects, especially in regulated environments.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and get you on our radar quickly!
How to prepare for a job interview at Next Phase Recruitment Limited
✨Know Your Standards
Make sure you brush up on ISO 13485, ISO 14971, and 21 CFR 820. These are crucial for the role, so being able to discuss them confidently will show that you're serious about compliance and quality.
✨Showcase Your Experience
Prepare specific examples from your past work where you've led design control and risk management activities. Highlight how you ensured deliverables were accurate and compliant, as this will resonate well with the interviewers.
✨Understand the Role's Collaboration Aspect
Since this is a hands-on, collaborative role, be ready to discuss how you've worked closely with development teams in the past. Share instances where your input made a difference in the product lifecycle.
✨Be Audit-Ready
Familiarise yourself with what it means to keep work audit-ready. Discuss any experiences you have with internal or external audits, and how you contributed to maintaining compliance throughout the process.