Senior Quality Officer
Core
Maintain the Quality Management System (QMS) for a clinical diagnostic laboratory, ensuring compliance with ISO 15189 and ISO 9001 standards while supporting continuous improvement initiatives.
Role type
Senior Quality Officer (Clinical Laboratory)
Builds
Quality documentation, policies, procedures, and audit reports for medical testing services.
Domain
Life Sciences / Clinical Diagnostics / Medical Laboratory Services
Deliverable
dashboards & analysis
Required skills
ISO 15189 compliance, CAPA management, internal/external audit coordination, risk management, QMS documentation, LIMS/QPulse systems knowledge, regulatory requirements analysis
Preferred skills
Q-Pulse platform experience, INAB requirements knowledge, medical laboratory working experience
Technologies
QPulse, Laboratory Information Management Systems (LIMS)
Responsibilities
Support and maintain the laboratory's Quality Management System (QMS), ensuring compliance with ISO 15189, ISO 9001, regulatory requirements, and Eurofins Group standards; Coordinate and participate in internal and external audits, including preparation of documentation and follow-up of audit findings; Monitor, analyse, and report on key quality metrics and departmental KPIs to support business performance and compliance objectives; Deliver training and support to employees on quality systems, procedures, and electronic quality management platforms (QPulse).