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About the role
- Internal Auditor responsible for planning and executing audits in medical laboratories. Ensuring ISO compliance and quality management in clinical diagnostics operations.
Responsibilities
- Develop and maintain a risk-based internal audit program covering clinical laboratory sites and processes (pre-analytical, analytical, post-analytical, support).
- Define audit scope, objectives, and resources, ensuring alignment with ISO 15189 and management priorities.
- Coordinate with site leaders/labs to schedule audits, communicate logistics, and share documentation requirements.
- Execute audits through document review, staff interviews, and direct observation of laboratory processes and workflows.
- Assess whether the laboratory meets its own QMS requirements, ISO 15189 clauses, and is effectively implemented.
- Monitor conformity, identify nonconformities, and document findings with clear reference to requirements and evidence.
- Prepare clear, factual audit reports summarizing findings, nonconformities, observations, and strengths.
- Present results to site management, QA leadership, and other stakeholders.
- Monitor the implementation of corrective and preventive actions (CAPA) resulting from audits. Track progress, verify implementation, and assess effectiveness of actions taken.
- Escalate unresolved issues as needed to QA management or higher authority.
- Analyze audit findings over time to identify recurring issues, systemic weaknesses, root causes and improvement opportunities.
- Maintain audit records, checklists, evidence, reports, and audit logs, ensuring traceability and confidentiality.
- Ensure the audit process and documentation satisfy accreditation, regulatory, and internal audit standards.
Requirements
- Bachelor’s degree in Medical Laboratory Science, Biomedical Science, Clinical Chemistry, Biology, or other relevant scientific discipline.
- Proven experience (e.g. 5+ years) in clinical laboratory operations or quality roles ideally in clinical diagnostics and in ISO 15189 or equivalent environments.
- Formal auditing training or certification (e.g. ISO internal auditor, auditor lead) preferred.
- In-depth knowledge of ISO 15189, quality systems, laboratory operations, and regulatory requirements.
- English fluent as a must (presenting, writing, reading).
- Strong analytical thought process and attention to detail.
- Excellent communication, report writing, and interpersonal skills.
- Ability to be impartial, objective, and maintain confidentiality.
- Willingness to travel across Europe between laboratories on a regular basis.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
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