Quality Officer

As a quality officer at a national center for infectious disease research, diagnostics, and laboratory surveillance, you play a crucial role in monitoring and ensuring quality standards within a medical laboratory, accredited according to the ISO 15189 guideline. The center monitors the spread of human infectious diseases and conducts highly specialized research into rare or complex pathogens. The team works on both projects and general tasks in the field of Quality, Health and Safety (HSE), and Environment.

Concrete projects include the implementation of legislation and regulations concerning in-vitro diagnostic medical devices and the management of quality and environmental management systems according to ISO 9001 and ISO 14001 standards. Preparations are also being made for changes to the quality system due to an upcoming relocation to a new laboratory. As a senior quality officer, you also contribute to the professionalization of the department.

You ensure that all diagnostic and research activities continue to comply with applicable accreditations and certifications.

What you will do.

• Monitor and ensure quality standards within the medical laboratory
• Implement legislation and regulations for in-vitro diagnostic medical devices
• Manage quality and environmental management systems according to ISO 9001 and ISO 14001 standards
• Prepare for changes to the quality system due to an upcoming relocation
• Prepare and guide internal and external audits
• Independently and constructively address points of attention, deviations, and (near-)incidents
• Coordinate reports and translate them into concrete improvement points
• Develop and manage risk analyses for primary processes
• Gather practical information from laboratory staff and experts
• Report progress to management

What they ask

• Minimum 7 years of relevant demonstrable work experience in the field of Quality, Health and Safety (HSE), and Environment in accredited laboratories (ISO 15189 or comparable)
• Valid driver's license
• Fluent command of the Dutch language (B2 or higher or native speaker)

Preferences.

• Completed relevant education(s) in the biomedical field, preferably in virology, bacteriology, or infectious diseases
• University degree in the biomedical field