At a Glance
- Tasks: Lead design controls and risk management for innovative medical devices.
- Company: Global biopharma organisation with a focus on advanced medical technology.
- Benefits: Hybrid work model, competitive pay, and opportunities for professional growth.
- Other info: Join a dynamic team dedicated to innovation and excellence in patient care.
- Why this job: Make a real difference in healthcare by ensuring compliance and quality in medical devices.
- Qualifications: 2+ years in medical devices, strong knowledge of regulatory standards.
The predicted salary is between 40000 - 50000 £ per year.
A global biopharma organisation is expanding its Devices Centre of Excellence in Cambridge, UK. We are seeking an experienced contract Quality Engineer (Compliance) to support advanced medical device and drug-device combination product programmes. This is a hands-on, consultative contract role embedded within product development teams, ensuring design controls and risk management activities are completely audit-ready across the lifecycle from early development to clinical supply.
Key Responsibilities & Measurable Goals
- Design Controls & Risk Management (Target: 100% compliance across DHF/RMF deliverables)
- Lead design control and risk management activities for assigned programmes, ensuring deliverables are accurate, approved, and maintained.
- Support and facilitate risk management workshops with external design and manufacturing partners.
- Provide quality engineering input into design validation activities, including Human Factors Engineering (HFE) and usability assessments.
- Regulatory Compliance & Auditing (Target: Zero major audit non-conformances)
- Ensure strict compliance with key standards and regulations, including ISO 13485, ISO 14971, 21 CFR 820, and EU MDR.
- Assess external partners and suppliers for QMS capability, compliance, and regulatory readiness.
- Support root-cause investigations into device issues arising from clinical trials and contribute quality content to regulatory submission documentation.
Key Requirements & Qualifications
- Experience: 2+ years of contract or permanent experience focusing on medical devices or combination products within a strictly regulated environment.
- Technical Mastery: Practical experience creating, reviewing, and maintaining Design History Files (DHF) and Risk Management Files (RMF).
- Standards & Regulations: Working knowledge of ISO 13485 / ISO 14971 / 21 CFR 820 / EU MDR with the ability to apply them pragmatically to moving deadlines.
- Education: BSc/MSc/PhD in a relevant science or engineering discipline.
- Work Authorisation: Must possess valid right to work in the UK for contract assignments.
Nice to Haves
- Familiarity with EN 62366, EN 60601, or EN 62304.
- Good understanding of GMP principles.
Quality Engineer (Compliance) in Cambridge employer: Next Phase Recruitment Limited
Join a leading global biopharma organisation in Cambridge, UK, where innovation meets compliance in the medical devices sector. As a Quality Engineer (Compliance), you will thrive in a collaborative and dynamic work culture that prioritises employee growth and development, offering opportunities to engage with cutting-edge projects while ensuring regulatory excellence. Enjoy the benefits of a hybrid working model, competitive remuneration, and the chance to contribute to life-changing medical advancements in a vibrant city known for its rich history and academic prowess.
Contact Details:
Next Phase Recruitment Limited Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Quality Engineer (Compliance) in Cambridge
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We think you need these skills to ace Quality Engineer (Compliance) in Cambridge
Some tips for your application 🫡
Showcase Relevant Lab Skills:In the biotech world, your lab skills are paramount. Make sure your CV highlights specific techniques and equipment you’ve used, such as PCR, gel electrophoresis, or cell culture. This will give us a clear picture of what you can bring to Next Phase Recruitment Limited as a temporary teammate.
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Keep It Concise and Relevant:Especially for a temporary role, we want to see a clear and focused application. Tailor your CV and cover letter to emphasise the qualifications and experiences that are most relevant to the biotech field and the specific role at Next Phase Recruitment Limited. This shows us you’re genuinely interested and capable.
Be Clear About Your Availability:Since it’s a temporary role, let us know right away when you’re available to start and how long you can commit. Include this in your cover letter — this kind of transparency saves us all time and helps us find the right fit quickly at Next Phase Recruitment Limited.
How to prepare for a job interview at Next Phase Recruitment Limited
✨Brush Up on Your Biotech Basics
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Since this is a temporary role, they’re likely looking for someone who can jump in and get up to speed quickly. Share experiences where you’ve adapted to new environments, tools, or teams in a short space of time. It shows you're ready to tackle the challenge head-on!
✨Emphasise Your Lab Experience
If you’ve got hands-on experience in lab settings, now’s the time to showcase it. Talk about specific techniques you’ve mastered, like PCR or chromatography, and any relevant safety protocols you’ve followed. These details help paint you as an effective team member from day one.
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