Marlena Świder-Biedziak

Head of QA/RA at Aether Biomedical

Marlena Świder-Biedziak has over 13 years of experience in the Quality Assurance and Regulatory Affairs field. Marlena is currently the Head of QA/RA at Aether Biomedical since 2021. From 2013 to 2021, they were at LiNA Medical where they held the roles of RA Officer and Change Control Coordinator - Laboratory Specialist, where they were the key user of BOM in AX 2012, supervised changes related to product and production process, and created risk analysis. From 2012 to 2013, they were at SP Medical A/S as a QA Coordinator, where they handled CAPA, provided training in hygiene, conducted environmental monitoring, supervised the company cleanup, released medical devices for sale, supervised changes CR and more. From 2008 to 2012, they were at Unilever as a Quality Assurance Laboratory Specialist - Microbiologist and QA Specialist.

Marlena Świder-Biedziak obtained a Master's engineer degree in Towaroznawstwo from the University of Warmia & Mazury in Olsztyn between 2002 and 2007. In 2013, they obtained a postgraduate degree in Microbiology, Hygiene and Quality in Manufacturing from the University of Warsaw. Additionally, they have obtained a number of certifications, including Quality Management System according to ISO 9001, HACCP and The management and Quality Audit in accordance with standard ISO/IEC 17025 from the University of Warsaw in 2013, Food safety management according to ISO 22000:2005 standard from BD Long in 2007, and Ensuring the quality of the results of the microbiological test from Merck in 2009.

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