🌟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
* 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)
💰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! 💬