Senior Kwalitietsfunctionaris ISO 15189
Core
Lead the development, implementation, and maintenance of the quality management system for an ISO 15189-accredited diagnostic organization.
Role type
Senior Quality Officer (ISO 15189)
Builds
Quality management systems and accreditation compliance for clinical diagnostic laboratories
Domain
Healthcare / Clinical Diagnostics / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ISO 15189 expertise, Root Cause Analysis (RCA), CAPA management, internal and external audit execution, risk and impact analysis, stakeholder advisory
Preferred skills
NEN 7510 knowledge
Technologies
ISO 15189, ISO 9001, NEN 7510
Responsibilities
Advise management and process owners on quality issues and policy; Monitor compliance with ISO 15189, ISO 9001, and regulations; Execute internal audit programs and guide external audits; Lead complex Root Cause Analyses and CAPA projects; Evaluate deviations, complaints, and incidents; Initiate corrective and preventive actions; Conduct risk and impact analyses; Lead organization-wide improvement projects; Provide training on quality management.
Seniority
Senior, hands-on IC