Quality Assurance and Auditing
Senior Consultant Medical Devices
Dr. Alexandra Beer has joined the Qserve Group as a Senior Consultant in Quality Assurance & Audits and is based in Germany.
Introduction
Alexandra holds a PhD in Technical Chemistry (ETH Zurich, CH) and a Master of Business Administration (MBA, Estema, Valencia, Spain). 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.
Alexandra about working at Qserve
Working at Qserve offers me broad access to experts in different areas all around medical devices with whom I can exchange ideas, discuss best practice approaches and learn. As well, I can bring my knowledge and experience and share it with colleagues who are interested in it and with whom we develop the best approaches for our customers. I love Qserve’s team spirit and culture and I am excited to form part of the team.
Before Qserve
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, or as an auditor for NB, she audited various medical device companies checking their compliance with applicable standards.
Furthermore, Alexandra worked as manager of the verification and validation department, as director of quality systems & regulatory & quality control laboratory, as regulatory affairs manager, as quality manager, and as safety officer. From these positions as well as working experiences in Switzerland, Spain, France, USA, and Germany she gained broad experience and knowledge in the medical device field. She is fluent in English, German, and Spanish and also speaks French on a conversational level.
The key expertise areas of Alexandra:
- Quality (System) Management: (interim) QA management roles. Creating, implementing, maintaining, and improving Quality Management Systems in compliance with ISO 9001 & ISO 13485 standards, Medical Device Directive 93/42/EEC, EU MDR 2017/745, and FDA 21 CFR Part 820 (QSR) regulations
- Quality Systems Projects: integration of new requirements, harmonization, increase of efficiency, KPI management, establishing audit readiness for unannounced audits
- Auditing: Preparing and performing internal ISO 9001 & ISO 13485 quality system audits as Lead Auditor, MDR gap assessments/audits. Extended experience in supplier audits and in preparing and participating as an auditee in audits from Notified Bodies
- Mock Audits: Conduction of Mock audits based on FDA requirements, international standards (e.g. ISO 9001, ISO 13485), European legislation, and unannounced audits
- Elaboration of technical documentation (TD) & Pre-Review of technical documentation that is to be handed over to NBs
- Set-up up risk management and review of risk management files (ISO 14971)
- Establish a Post Market Surveillance System according to MDR/IVDR
- Computer Software Validation, manufacturing process validation
- Training activities on relevant quality and regulatory topics
- Usability Files according to IEC 62366
- Led CAPA projects and CAPA board meetings, improving CAPA performance