Senior Quality Specialist

Senior Quality Specialist | Medical Devices & IVD | Guildford

Are you a experienced quality professional who thrives in regulated medical device and diagnostics environments? If you want to take ownership of quality outcomes, influence company-wide standards, and help build quality systems that support innovation and growth, this position is for you.

An innovative diagnostics organisation developing and commercialising liquid biopsy technologies and advanced diagnostic solutions. Working at the intersection of precision medicine, oncology, and medical devices, the company is entering an exciting phase of growth and product development.

With a culture built around ownership, curiosity, collaboration, and continuous improvement, the business offers a unique opportunity to shape quality practices in a fast-moving, entrepreneurial environment while supporting technologies with real patient impact.

As Senior Quality Specialist, you will be responsible for maintaining and enhancing the company's ISO 13485-certified Quality Management System while driving quality initiatives from concept through implementation.

Working closely with R&D, Operations, Commercial and Executive Leadership teams, you will provide expert quality guidance, support regulatory compliance, lead audits, and help embed a culture of quality across the organisation.

• Ensure compliance with ISO 13485, IVDR, UK Medical Device Regulations and UKCA requirements
• Lead internal audits and coordinate external audits and inspections
• Apply risk management principles in accordance with ISO 14971

• Strong working knowledge of ISO 13485, GMP and regulated environments
• Experience supporting CE-marked and/or UKCA-marked products
• Experience working with eQMS platforms
• A proactive, solutions-oriented and highly organised approach

If you are excited by the opportunity to build scalable quality systems while supporting innovative diagnostic technologies, we'd love to hear from you.