Qserve Group is pleased to announce that 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 look forward to 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.“
Christie brings to Qserve her versatile knowledge of quality assurance and regulatory affairs with hands on experience in quality management systems, regulatory affairs, project management and clinical affairs. Christie’s career has prepared her to embrace the ever-changing regulations in the industry and pass her knowledge and experience onto Qserve clients.
Christie 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. She joins the US team and will be operating out of Austin, Texas. She will be working with the IVD team as a Consultant and will service our global clients as they prepare for the IVDR in 2022.
About Qserve Group
Qserve’s mission is to support all medical device and in-vitro diagnostics manufacturers with a practical approach, translating existing regulations to understandable requirements. We serve to guide manufacturers in gaining and maintaining compliance as well as conducting clinical studies as a CRO to ensure safe and quality devices in the most streamlined way possible. Qserve’s global team combines its regulatory and clinical knowledge and experience in the medical device industry, sharing more than 900 years’ worth of combined expertise in the medical field. Having teams in the EU, USA, and China provides a global footprint for global regulatory, clinical, CRO and quality services.