Lab Quality Specialist

Job description

Location: Full time on site — Oxford (Kidlington), UK Travel: Occasional travel to our Exeter site, typically around once a quarter, usually tied to audits About the role We're looking for a Laboratory Quality Specialist to join our UK quality team and help keep our digital pathology laboratory operations running compliantly and well. This is a hands-on, on-the-floor quality role. You'll be the person the lab team comes to. You'll be driving incidents through to closure, following up CAPAs and engineering change orders, keeping the risk register current, and making sure internal and supplier audits actually happen on time. You won't be expected to fix the lab's technical problems yourself — that's the lab team's job — but you will be the one making sure things are investigated properly, documented, actioned and closed. We work to ISO 15189:2022 and hold UKAS accreditation, so there's real rigour here. There's also a genuine backlog to work through, which means you'll see the impact of your work quickly. What you'll be doing Managing non-conformances end to end — quality issues, security incidents and customer complaints — recording them properly and working with Operations to complete the documentation Coordinating root cause investigations and following corrective and preventive actions through to closure Driving CAPAs and engineering change orders (ECOs) forward, chasing actions and keeping owners accountable Conducting internal and supplier audits, and helping maintain the laboratory audit calendar Supporting UKAS accreditation to ISO 15189:2022 — collating evidence, closing non-conformities and verifying changes were implemented effectively Maintaining and improving laboratory SOPs and quality documentation Maintaining the quality risk register and supporting risk reviews with stakeholders Bringing visibility to lab quality actions — for example, visual management in the lab so open actions are seen and closed, not lost in a system Compiling monthly error log reports and trend analysis for KPI reviews Monitoring EQA and UK NEQAS scheme participation and performance Supporting change in the lab so it happens the right way round — SOP updated, training and competency completed, records in place — rather than the team playing catch-up afterwards Supporting training and competency so lab staff understand their own role in quality and compliance About you Essential Solid quality assurance experience in a regulated environment — ISO 15189 or ISO 13485 Experience in diagnostics or healthcare (rather than pharmaceutical manufacturing) Practical, day-to-day experience of incidents, CAPAs, change control and audits Internal auditing experience Strong follow-through — you're comfortable chasing people, holding owners to deadlines and keeping things moving without being the bottleneck Excellent interpersonal skills and the ability to work effectively as part of a team Good written and spoken English Nice to have Bachelor's degree in Biomedical Science, life sciences, engineering or similar Knowledge or experience of histopathology and/or digital pathology Familiarity with quality systems such as Qualio or Greenlight Guru Six Sigma or other process improvement certification Experience with generative AI tools and technology If you have strong quality experience but not a histopathology background, we'd still like to hear from you. The quality fundamentals matter most. About the Company Diagnexia , a subsidiary of Deciphex: Accelerating Certainty and Pioneering Pathology Services. Diagnexia , a leading provider of pathology services, operates as a subsidiary of the parent company, Deciphex. Established in Dublin in 2017, Deciphex has rapidly expanded to become a global team of over 230 professionals, offering innovative software solutions to address the pathology gap in both research and clinical areas. With a mission to accelerate the drug development process and provide timely, accurate diagnoses for cancer patients, Deciphex has established a strong presence through its offices in Dublin, Exeter, Oxford and Chicago. As part of the Deciphex family, Diagnexia leverages its expertise to provide cutting-edge diagnostic solutions to healthcare organizations worldwide. Our cloud-based platform enables hospitals to easily and rapidly send cases for a consultation to our team of expert subspecialists. We are dedicated to improving patient outcomes and helping healthcare organisations stay at the forefront of the industry. We are software developers, clinical specialists, AI engineers, operations professionals and so much more, all working as one team to support our customers and patients. Our team culture is built on trust. We give our team the space they need to deliver results and the environment to ensure they can enjoy doing it. We are looking for highly motivated individuals who are excited to take on challenges and value making a difference in their day-to-day work. This is a unique opportunity to make a difference in the emerging Digital Pathology field. What are the benefits of working with Diagnexia ? Healthcare benefits Competitive paid time off A true sense of meaning in your work by contributing to better patient outcomes. The opportunity to work alongside a world-class high performing team in a hyper-growth startup environment. A chance to work on exciting, challenging and unique projects. Regular performance feedback and significant career growth opportunities. A highly collaborative and supportive multi cultural team. Diagnexia is an equal opportunities employer and we are committed to the principle of equality. All qualified applicants will be considered for employment without regard to age, race, religious beliefs, political views, gender identity, affectional or sexual orientation, national origin, family or marital status (including pregnancy), disability, veteran status, membership of the travelling community or any other classification protected by applicable law.