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!