Lab Quality Specialist - ISO 15189 & Audit Lead

Deciphex Limited; Oxford; Hybrid; GBP 45,000 - 60,000; Full time

Benefits offered by this job

Healthcare benefits

Competitive paid time off

Career development

Job summary

Diagnexia, a subsidiary of Deciphex, seeks a Laboratory Quality Specialist to drive quality processes on the lab floor, manage incidents and CAPAs, and ensure audits run on time. The role supports ISO 15189:2022 and UKAS accreditation, with a focus on practical, hands-on quality leadership within the team.

You’ll work to maintain SOPs, risk registers, and robust documentation while coordinating with Operations and suppliers to close actions efficiently.

Qualifications

• Solid QA experience in ISO 15189 or ISO 13485.
• Experience in diagnostics or healthcare (not pharma).
• Experience with incidents, CAPAs, change control and audits.
• Internal auditing experience.
• Excellent interpersonal skills and ability to work in a team.
• Good written and spoken English.

Responsibilities

• Manage non-conformances end to end and coordinate with Operations for documentation.
• Coordinate root cause investigations and ensure corrective actions through to closure.
• Drive CAPAs and engineering change orders (ECOs) and track actions to owners.
• Conduct internal and supplier audits and maintain the laboratory audit calendar.
• Support UKAS accreditation to ISO 15189:2022 and verify changes were implemented.
• Maintain and improve laboratory SOPs and quality documentation.
• Maintain the quality risk register and support risk reviews with stakeholders.
• Provide visibility to lab quality actions and KPI reporting.
• Monitor EQA and UK NEQAS participation and performance.
• Support training and competency so lab staff understand their role.

Skills

Quality assurance

Internal auditing

Interpersonal skills

English communication

Team collaboration

Education

Bachelor’s degree in Biomedical Science/ Life sciences/ Engineering

Six Sigma or process improvement certification

Tools

Qualio

Greenlight Guru

Job description

Diagnexia, a subsidiary of Deciphex, seeks a Laboratory Quality Specialist to drive quality processes on the lab floor, manage incidents and CAPAs, and ensure audits run on time. The role supports ISO 15189:2022 and UKAS accreditation, with a focus on practical, hands-on quality leadership within the team.

You’ll work to maintain SOPs, risk registers, and robust documentation while coordinating with Operations and suppliers to close actions efficiently.