Lab Quality Specialist

About the role

We are looking for a Laboratory Quality Specialist to join our UK quality team and ensure our digital pathology laboratory operates compliantly and efficiently. The role is hands‑on, on‑the‑floor, supporting incident closure, CAPA management and audit coordination while maintaining ISO 15189:2022 and UKAS accreditation.

Key responsibilities

• Manage non‑conformances, security incidents and customer complaints from recording to closure.
• Coordinate root‑cause investigations and drive corrective and preventive actions (CAPAs) and engineering change orders.
• Conduct internal and supplier audits and maintain the laboratory audit calendar.
• Support UKAS accreditation to ISO 15189:2022 by collating evidence and closing non‑conformities.
• Maintain and improve SOPs, quality documentation, risk register and monthly error‑log reports.
• Monitor EQA and UK NEQAS scheme participation and performance.

Required profile

• Solid quality‑assurance experience in a regulated environment (ISO 15189 or ISO 13485).
• Background in diagnostics or healthcare, with hands‑on experience of incidents, CAPAs, change control and audits.
• Strong follow‑through and interpersonal skills, able to hold owners to deadlines.
• Excellent written and spoken English.

Required skills

• ISO 15189
• ISO 13485
• CAPA management
• Engineering change orders (ECO)
• Internal auditing
• Qualio or Greenlight Guru
• Six Sigma
• Generative AI tools

What we offer

• Healthcare benefits
• Competitive paid time off
• Meaningful work contributing to patient outcomes
• Opportunity to work with a high‑performing team in a hyper‑growth startup
• Challenging and unique projects
• Regular performance feedback and career growth opportunities
• Collaborative multicultural environment