IVD, US FDA & EU Regulatory & Quality expert, CDx
Christie Hughes has joined Qserve to further expand its capabilities in supporting the in vitro diagnostics and medical device industries worldwide. With over 20 years’ experience, Christie has built up strong competences in the IVD sector around quality, regulatory, auditing and training.
Jan van Lochem (CEO): “I am exited having Christie as part of our global team. Her knowledge and experience will help to further expand our IVD competences and build up a global leading IVD consultancy.“
Key expertise areas of Christie
- Her versatile knowledge of quality assurance and regulatory affairs with hands on experience in quality management systems, regulatory affairs, project management and clinical affairs.
- She has built her experience in industry at IVD multinationals Luminex and Thermo Fisher Scientific between 1996 and 2016. She held roles there as QA Manager, Quality & Compliance Manager, QA Director, Product Manager for microRNA tests, and Senior Manager Regulatory Affairs.
- Since 2017, Christie has run her own consulting firm Integrys Consulting from where she has done several projects in the QA/RA IVD area for both Qserve and her own firm.
Christie has a master’s in public health degree in epidemiology and a bachelor’s degree in biology / medical technology from universities in Texas. In addition, she is a certified medical technologist (medical laboratory scientist) through the American Society for Clinical Pathology and a certified quality auditor through the American Society for Quality (ASQ). She has also had training in FDA Clinical Trial requirements.
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