A leading medical device manufacturer based in South Wales is seeking a Senior Quality Design Engineer to join its Quality team. This senior position plays a key role in providing quality leadership across new product development (NPD) and design change activities, with a strong emphasis on risk-based decision-making, prevention, and continuous improvement. Working closely with R&D, Clinical, Operations, and other cross-functional teams, the Senior Quality Design Engineer will act as a subject matter expert in design quality and risk management, ensuring products meet quality and regulatory expectations throughout the full product lifecycle. Your responsibilities as a Senior Quality Design Engineer will include: * Providing quality leadership across NPD and design change programmes * Acting as subject matter expert for design quality and ISO 14971 risk management * Leading and reviewing PHAs, pFMEAs, dFMEAs, Risk Management Plans (RMPs), and Risk Management Reports (RMRs) * Reviewing and approving validation strategies, protocols, and reports * Leading cross-functional risk reviews, investigations, CAPAs, non-conformances, and HHEs * Challenging and approving change management from a risk and validation perspective * Mentoring R&D and cross-functional teams on quality principles and risk-based approaches * Acting as quality SME during internal and external audits * Deputising for management at design reviews and governance forums To be successful as a Senior Quality Design Engineer, you will need: * 5 years’ experience in medical devices within Quality or Design Quality Engineering * Strong working knowledge of ISO 13485, ISO 14971, GDP, and GMP * Solid understanding of medical device design, development, and manufacturing processes * Experience supporting technical documentation and regulatory submissions * Excellent communication skills with strong attention to detail * Proven analytical thinking, problem-solving ability, and stakeholder engagement skills Desirable experience includes: * Lean Six Sigma training or certification * Experience using statistical tools such as Minitab * Familiarity with EU MDR requirements This is a pivotal role within a global medical device organisation, offering the opportunity to influence design quality strategy, shape risk management practices, and support the delivery of safe, compliant products to market. The role also provides a fast-paced environment to learn new skills quickly, gain exposure to cross-functional teams, and access clear opportunities for career progression within the company. Please note, applicants must already have the right to work in the UK, as visa sponsorship is not available. Senior Quality Design Engineer | Design Quality | Risk Management | ISO 13485 | ISO 14971 | NPD | Medical Devices | Learning & Development | Career Progression | South Wales Job ID: 84310