Alexandra C. has a diverse work experience in quality systems engineering, quality management, product development, and production science. Alexandra is currently working at Cumulus Neuroscience as a Senior Quality Systems Engineer. Prior to this, they were a Quality Engineer at the same company. In 2021, they worked as a Product Development Engineer at Terumo Blood and Cell Technologies. From 2019 to 2021, they were a Quality Management Specialist at Meddev Solutions. Alexandra started their career as a Production Scientist at LINNODEE LIMITED from 2017 to 2019.
Alexandra C. completed their Bachelor of Science - BSc Hons degree in Biology/Biological Sciences, General from Ulster University, where they studied from 2012 to 2017. Additionally, they obtained various certifications in different areas such as medical device risk and design controls, computer software assurance, ISO 13485, modernizing quality management systems, risk management, FDA quality management system regulation, eMDR program and process, CAPA for the medical device industry, ISO 19011:2018, product environmental compliance, RoHS, REACH, SVHC and SCIP compliance for articles, global regulatory strategy for pharmaceuticals, software for medical devices and IEC 62304, ISO 13485 lead auditor, MD-QMS ISO 14971:2019 foundation training course, QMS foundation based on ISO 13485:2016, and RAPS membership. The dates of obtaining these certifications range from 2021 to 2022.
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