Job Description:

About the Role 

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 

You’ll act as a quality SME for device and combination product development, with responsibilities including: 

• 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 settin 

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.