Head of Quality Laboratories - Sweden
UnilabsJob Description
The National Head of Quality Laboratories is a senior leadership role responsible for developing, implementing, and maintaining a robust Quality Management System (QMS) across our network of clinical laboratories. This role ensures compliance with ISO 15189:2022, EU IVDR (including Article 5(5) for in-house IVDs), and all applicable national regulatory requirements.
The National Head of Quality Laboratories will drive a culture of quality excellence, continuous improvement, and patient safety while serving as the primary quality representative to accreditation bodies, regulatory authorities, and key stakeholders.
Quality Management System Leadership
· Lead the maintenance and continuous improvement of the quality management system (QMS) across all laboratory sites.
· Develop and maintain quality policies, procedures, and work instructions aligned with ISO 15189:2022 requirements.
· Establish and monitor quality objectives that su...
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