Senior Quality Engineer

Accelero Pontypridd, Wales, United Kingdom

Accelero Pontypridd, Wales, United Kingdom

Direct message the job poster from Accelero.

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.

• 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 a 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 ELLE effectiveness
• Providing technical direction on validation methods and statistical sampling plans
• Participating inaign 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

• 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 Power Point
• 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
• 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)

• 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! 💬

Mid‑Senior level

Full‑time

Quality Assurance and Engineering

Manufacturing