Quality Director IVD Projects

Agnes Goris (born 1961, Belgian citizen) obtained a Master Degree in Biology and a Postgraduate Degree in Biotechnology at the Catholic University of Leuven. After 16 years working in the IVD industry, Agnes joined Qarad in 2002. In the meantime, she became Quality Director of IVD Projects.

In this function, she combines her Regulatory knowledge with her practical IVD experience to guide her team to excellence. Agnes can ensure smooth introduction of your products to the European market, since she can assist you with:

• Organization and monitoring of performance studies of In Vitro Diagnostic assays
• Composition and review of technical documentation for In Vitro Diagnostics and other Medical Devices
• Follow-up of submissions with Notified Bodies.
• Notification of IVD/MD to different European Competent Authorities
• CLP and REACH requirements for IVD products

In the last 10 years, Agnes managed Performance Studies for many customers for different types of IVD products, like HIV, HBV, HCV, Syphilis, CMV markers, ABO typing reagents.

Previous experience

Before joining Qarad, Agnes worked for major companies such as Sanofi Diagnostics Pasteur, Innogenetics N.V. (now: Fujirebio) and Genzyme where she held functions in R&D (development of Immunodiagnostic assays for microbiological markers, HIV and HCV), Quality Control (batch release, method validation and implementation of statistical process control) and Regulatory Affairs (compilation of registration files).

Sue Schiepers, MBA

Business Operations Manager & Privacy Manager

Sue Schiepers graduated in Art Sciences, after which she obtained a post-graduate degree in Corporate Economics from the Catholic University of Leuven. She expanded her knowledge by obtaining an Executive MBA at the Antwerp Management School. Sue joined Qarad in 2019 as Business Operations Manager. She assists the management in organising day-to-day activities of Qarad and as such Sue is responsible for Human Resources, office management, finances and much more. 

Rika Verduyckt

Office Assistant