Senior Quality Engineer
1 day ago
Pontypridd
🌟Senior Quality Engineer 📍 Pontypridd 💷 £42,000 - £52,000 (dependent on experience) 🏡 1 day WFH per week We’re 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. 🔍 What you’ll 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 we’re 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, • 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) 💰Salary & Benefits • £42,000 - £52,000 (dependent on experience), • 33 days holiday (inclusive of bank holidays) plus holiday trading scheme, • Pension, • Life assurance, • Plus additional benefits If you think this is a good fit for you, please apply or send a message! 💬