Hybrid Internal Auditor – Medical/Clinical Laboratories

at Unilabs

• Job title: Internal Auditor – Medical/Clinical Laboratories
• Job type: Contract
• Experience level: Mid level, Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Porto, Portugal

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.