Qserve Group is pleased to announce that Olena Hoi has joined our team as consultant to further expand her capabilities in supporting the medical device industries worldwide.
Working for Qserve Group, Olena works as part of the Quality and Regulatory Affairs team with various low/high-risk devices under the EU MDR.
Olena is originally from Ukraine and before joining Qserve, she worked in the Quality Assurance department at a biotechnical company in Taiwan. G
aining valuable experience with Class III devices under EU medical device (MDD/MDR) regulation and across various other international emerging markets.
She was also responsible for global market registration and completed several registration projects in Asia and Eastern Europe. Olena started her career as a Quality Auditor at the Ukrainian Conformity Assessment Body and performed over 100 overseas quality management system audits. Olena holds degrees in Physics of Functional Materials from Taras Shevchenko National University of Kyiv (MSc). She also obtained a secondary degree – Bachelor of Arts in Theology, Ministry, and Mission with her MSc. Olena holds Lean Six Sigma Yellow Belt: Quantitative Tools for Quality and Productivity issued by Technische Universität München.
With such a background, Olena fits perfectly in the multi-cultural environment Qserve is. She is fluent in Russian, Ukrainian and English.
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.
Qserve is constantly looking for consultants at different career levels with experience in regulatory affairs, quality assurance, clinical affairs or auditing in medical devices. Check our current vacancies