Quality Engineer, Compliance Location: Cambridge, UK (Hybrid 2.5 days per week onsite) About the Role Join the Biotherapeutics Pharmaceutical R&D Devices Centre of Excellence, where youll play a key role in ensuring quality and compliance for medical devices and combination products throughout their lifecycle. This position focuses on design control and risk management, supporting development programs from early design through to commercial launch. Youll work closely with cross-functional teams and external partners to maintain the highest standards of quality and regulatory compliance. Key Responsibilities Lead design control and risk management activities for combination product development, ensuring all deliverables are accurate, approved, and audit ready. Facilitate risk management processes with external design and manufacturing partners. Ensure compliance with internal and external quality and regulatory standards (ISO 13485, ISO 14971, 21 CFR 820, EU MDR). Provide input into design validation activities, including Human Factors Engineering assessments. Assess external suppliers for quality system capability and compliance. Support investigations into device issues from clinical trials and commercial manufacturing. Contribute to regulatory submissions for assigned device projects. Assist with internal and external audits of the Device Centre of Excellence Quality Management System. Education & Experience BSc/MSc/PhD in a relevant science or engineering discipline (e.g., Chemistry, Biology, Biomedical Sciences, Mechanical or Chemical Engineering). Minimum 2 years experience in pharmaceutical combination product and/or medical device industries. Proven experience in design controls and risk management for combination products. Familiarity with Human Factors Engineering and device assembly/manufacturing processes. Strong working knowledge of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, EU MDR. Technical Skills Understanding of EN 62366, EN 60601, EN 62304 standards. Ability to apply established procedures consistently and accurately. Strong attention to detail, organizational skills, and ability to manage multiple priorities. Excellent communication and interpersonal skills; able to work collaboratively in cross-functional teams. Proficiency in MS Office and general computer applications. Knowledge of GMP principles. Key Competencies Decisive: Synthesizes complex information to make informed decisions. Focused: Holds self and others accountable for delivering results. Connected: Builds strong relationships with internal and external stakeholders. Courageous: Demonstrates integrity and consistency between words and actions. Resilient: Adapts quickly to changing priorities and business needs.