Lab Quality Specialist

Deciphex • Oxford, NC

13d • Onsite

About The Position

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.

Requirements

• 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 Haves

• 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

Responsibilities

• 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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree