The Internal Auditor is responsible for planning, executing, and reporting internal audits across medical/clinical laboratories to evaluate conformity with ISO 15189:2022, the organization's quality management system, regulatory requirements, and internal policies. The auditor helps identify gaps, risks, and opportunities for improvement, and monitors corrective and preventive actions to ensure sustainable compliance and continuous quality enhancement.
Key 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
Education and Experience
· 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).
Required skills
· 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.