Quality Engineer, Compliance

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