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Quality Specialist / Manager

9-Month Fixed-Term Contract | Part-Time (3 days / 24 hours per week) | Hybrid – 2/3 days on site | UK

Biofidelity’s mission is to improve and extend the lives of patients with cancer by enabling better targeting of therapies, early detection of treatment resistance, and routine monitoring of treatment response. Our unique technology is designed to allow rapid, broad adoption of our assays in testing labs around the world, enabling a step change in patient care.

At Biofidelity, we are proud to have built a culture of humanity, openness and high expectations. We work towards well-defined goals, with a strong belief that we can bring real benefits to patients. Our people are keen to take responsibility for their work and share both their successes and challenges.

The Role

We are seeking a Quality Specialist or Quality Manager to join Biofidelity on a 9-month fixed-term contract, providing maternity cover.

This is a part-time role of approximately 3 days / 24 hours per week, with a hybrid working arrangement. The role will require approximately two-thirds of working time to be spent on site at our UK facility.

We are looking for an experienced quality professional with practical ISO 13485:2016 experience who can support the ongoing implementation, maintenance and development of our Quality Management System (QMS). Depending on experience, the successful candidate may operate at either Quality Specialist or Quality Manager level.

Reporting to the Executive Director of Operations, the role will provide hands-on quality support for the Quality Management System, including design and development activities, risk management and continuous improvement.

Key Responsibilities

• Maintain and support the ISO 13485:2016 compliance using the company eQMS.
• Support product and software development teams with design controls and risk management in accordance with ISO 14971:2019.
• Develop and deliver quality training across the company.
• Plan, initiate and support quality improvement and continuous improvement activities.
• Support quality investigations, non-conformances and complaint handling.
• Ensure appropriate quality requirements are applied to suppliers and subcontractors.
• Support the creation and maintenance of medical device/product files and contribute to the drafting and compilation of product documentation for these files.
• Provide practical quality guidance and support to colleagues across the organisation.
• Depending on experience and seniority, take ownership of elements of the QMS and act as a key quality lead within the business.

Knowledge, Skills and Abilities

• Practical experience working within, implementing or maintaining an ISO 13485:2016 Quality Management System.
• Experience in medical devices, in vitro diagnostics (IVDs), molecular diagnostics, reagents or consumables is highly desirable.
• Knowledge and practical experience of design and development controls and ISO 14971:2019 risk management.
• Familiarity with other applicable standards and regulations, such as IEC 62304 is desirable
• Experienced and trained internal auditor.
• Excellent organisational, communication and interpersonal skills.
• A proactive, practical and collaborative approach, with strong attention to detail.
• Ability to work independently, manage priorities and deliver effectively within a part-time, fixed-term role.

Education and Experience

• Degree or equivalent qualification in a science, medical, engineering or technical discipline.
• Demonstrable experience working within an ISO 13485:2016 environment, ideally with an eQMS.
• Experience in a quality role within the medical device, IVD, diagnostics or life sciences sector.
• Experience as a Quality Manager, Quality Lead, or Quality Specialist would be considered.
• ISO 13485 Lead Auditor qualification is desirable.
• Previous experience of managing or being responsible for a QMS is desirable, but the role is also open to an experienced Quality Specialist looking to take on broader responsibility.

Contract and Working Arrangements

• Contract: 9-month fixed-term contract (maternity cover)
• Hours: Approximately 24 hours / 3 days per week
• Location: UK
• Working pattern: Hybrid, with approximately 2/3 of working time on site
• Level: Quality Specialist or Quality Manager, depending on experience
• Candidates must have the right to work in the UK.

This is an opportunity to make a meaningful contribution to Biofidelity’s quality activities during an important period of growth and development, while working within a collaborative team focused on delivering innovative technologies that can benefit patients and research.

Biofidelity is an equal opportunities employer. We are committed to creating an inclusive working environment where all individuals are treated fairly and with respect. We welcome applications from all qualified candidates regardless of age, disability, gender identity or expression, marital or civil partnership status, pregnancy or maternity, race, religion or belief, sex, or sexual orientation. Employment decisions are based solely on merit, qualifications, and business needs.

We process your personal data in accordance with our Privacy Notice: https://biofidelity.com/privacy-notice/

To apply for this position, please submit your CV and a brief covering letter outlining your relevant experience and why you are interested in the role. Applications should be sent to info@biofidelity.com by 25th September 2026. Please use ‘Quality Specialist / Manager – Application’ as the email subject line.