Qserve Group is pleased to announce that Alexandra Beer has joined our team to further expand her capabilities in supporting the medical device industries worldwide.
Alexandra Beer has joined the Qserve Group where she is part of the Quality team and is experienced in Quality Assurance & Audits.
Alexandra holds a PhD in Technical Chemistry and a Master of Business Administration. She has more than 15 years of experience in setting up, maintaining, and improving quality systems and complying with regulatory standards, e.g. ISO 13485, ISO 9001, IVDR, MDR, MDD 93/42/EEC, FDA 21 CFR 820. She has broad experience in conducting internal and supplier audits, as well as mock audits.
Prior to Qserve, Alexandra worked for various Medical Device Companies (including IVD) and a Notified Body (NB). For example, as VP of Quality & Regulatory Affairs, Alexandra supported the company to integrate IVDR requirements into a company’s QMS, and as an auditor for NB.
She gained broad experience and knowledge in the medical device field with her different positions as manager of the validation department, director of quality systems & regulatory & quality control laboratory, regulatory affairs manager, quality manager, and safety officer.
There’s a personal profile
available on this website where Alexandra explains more about her experience and her core competencies.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 to support manufacturers or distributors of medical devices and in vitro diagnostics. Check our current vacancies