Were 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.
Salary & Benefits
Up to £32,000 base
1 day WFH per week
33 days holiday (inclusive of bank holidays) plus holiday trading scheme
Pension
Life assurance
Plus additional benefits
What youll 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 were 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)
TPBN1_UKTJ