Margherita Moroni

Margherita Moroni has a diverse background in the medical device industry. Margherita started their career in 2020 at AorticLab as a QA/RA Engineer, where they implemented and updated Quality Management System procedures, managed nonconformities, coordinated corrective actions and problem investigations, and participated in audits and supplier qualification. Margherita also collaborated with various internal departments for regulatory submissions and technical documentation, managed risk management and design control activities, and supported biocompatibility assessments and process validation.

In 2023, Margherita joined PQE Group as a Medical Device Compliance Expert. Margherita'sresponsibilities in this role include implementing and updating quality management system procedures, defining FDA and MDR regulatory pathways, supporting inspections and conformity assessments, preparing technical documents for regulatory release, and implementing and updating risk management and biological evaluation documents. Margherita also performs training activities and participates in interviews for marketing purposes.

Margherita Moroni has a strong educational background in the field of biomedical engineering. they obtained a Bachelor's degree in Biomedical Engineering from Politecnico di Milano in 2017. Following that, they pursued a Master's degree specializing in Biomechanics and Biomaterials within the same field at the same institution, which they completed in 2020. To enhance their language skills, they also completed an Intensive English Language Course at the Emerald Cultural Institute in 2017.

Prior to their university studies, Margherita obtained their High School Diploma from Liceo Statale "Melchiorre Gioia" in 2013, where they studied in the Scientific Lyceum.

In addition to their formal education, Margherita holds an Auditor qualification from the BSI Training Academy, which they obtained in May 2022. This qualification focuses on ISO 13485:2016 Internal Auditor Training. Margherita also has a TOIEC certification, the details of which are not provided in the information given.