Senior Quality Engineer

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

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