Were seeking an experienced Senior Quality Engineer to provide proactive quality leadership and technical direction across NPD and change management activities. This is a key role within the RAQA team, focused on prevention, risk-based thinking, and continuous improvement of products and processes while ensuring compliance with regulations and standards. Salary & Benefits Up to £32,000 base 1 day WFH per week 33 days holiday (inclusive of bank holidays) plus holiday trading scheme Pension Life assurance Plus additional benefits What youll be doing Working cross-functionally with R&D, Clinical, Operations, and other business teams to ensure strong quality performance Providing mentorship, technical review, oversight, and approval of validation plans, protocols, reports, and requirements specifications Acting as a senior expert in problem solving and root cause analysis Leading the development and improvement of quality processes for new and existing products using a risk-based approach Initiating and leading PHAs, pFMEAs, dFMEAs, RMPs, and RMRs Serving as Subject Matter Expert for risk management (ISO 14971), with deep expertise in process risk Leading regular cross-functional risk review meetings Acting as Site Process Owner for design quality and risk management Supporting investigations including HHEs, PFAs, NCs, and CAPAs Reviewing and approving change management activities, challenging risk, validation strategy, and effectiveness Providing technical direction on validation methods and statistical sampling plans Participating in and leading internal and external audits, acting as SME for design quality and risk management Coaching and mentoring R&D and cross-functional teams on quality principles and best practices Deputising for management in design review boards and business meetings as required What were looking for Essential: Strong proficiency in ISO 13485, ISO 14971, GDP, and GMP Strong hands-on experience as a Quality Engineer, ideally within NPD / Design Exposure to regulatory registrations and technical documentation submissions High level of expertise in risk-based approaches, particularly process risk and statistical sampling plans Excellent communication skills, attention to detail, and ability to act as the voice of Quality Strong leadership and mentoring behaviours Advanced problem-solving and analytical skills Proficiency in Microsoft Word, Excel, and PowerPoint Self-starter with the ability to manage multiple priorities in a fast-paced environment Willingness to work as part of a multi-site team, with some travel required Diplomatic, tactful, and able to influence outcomes across functions Strong stakeholder focus with a continuous improvement mindset Desirable: Degree in Biomedical engineering, mechanical engineering or similar. Experience using statistical tools such as Minitab Familiarity with regulatory frameworks Lean Six Sigma training (distinct advantage)