A leading medical device manufacturer based in South Wales is seeking a Senior Quality Design Engineer to join its RAQA team. This senior role provides quality leadership across new product development (NPD) and design change activities, with a strong focus on risk-based thinking, prevention, and continuous improvement.
Working closely with R&D, Clinical, Operations, and other functions, you will act as a subject matter expert in design quality and risk management, ensuring products meet regulatory and quality requirements throughout the lifecycle.
Key Responsibilities:
* Provide quality leadership across NPD and design change activities
* Act as SME for design quality and ISO 14971 risk management
* Lead and review PHAs, pFMEAs, dFMEAs, RMPs, and RMRs
* Review and approve validation strategies, protocols, and reports
* Lead cross-functional risk reviews and investigations (CAPA, NCs, HHEs)
* Challenge and approve change management from a risk and validation perspective
* Mentor R&D and cross-functional teams on quality and risk-based approaches
* Act as SME during internal and external audits
* Deputise for management at design reviews and governance meetings
Experience & Skills Required:
* 5+ years’ experience in medical devices in a Quality or Design Quality Engineering role
* Strong knowledge of ISO 13485, ISO 14971, GDP, and GMP
* Solid understanding of medical device design and manufacturing processes
* Experience supporting technical documentation and regulatory submissions
* Excellent communication skills and attention to detail
* Strong analytical, problem-solving, and stakeholder management skills
Desirable:
* Lean Six Sigma training
* Experience with statistical tools (e.g. Minitab)
* Familiarity with EU MDR
This is a key role within a global medical device organisation, offering the opportunity to influence design quality strategy and deliver safe, compliant products to market.
Senior Quality Design Engineer | Design Quality | Risk Management | ISO 13485 | ISO 14971 | NPD | Medical Devices