Marco Badiali

MD Compliance Manager at PQE Group

Marco Badiali began their work experience in 2013 as a Research Intern at Arts et Métiers ParisTech. Marco then joined LED SpA as a Product Certification Engineer, where they were responsible for compliance testing, risk management analysis, and documentation preparation. In 2014, they moved to Pharma Quality Europe S.R.L. as a Senior Validation Engineer, working on qualification activities for oral solids production and quality engineering tasks for Medtronic Brescia. Marco joined PQE Group in 2018 as a Senior Validation Engineer and later became the MD Compliance Manager. In this role, they were involved in test method validation for a flagship product and managed compliance activities.

Marco Badiali has a strong education background in the field of Medical Engineering. Marco began their academic journey at the University of Rome Tor Vergata, where they obtained their Bachelor's degree in Medical Engineering in 2009. Marco then pursued further studies at the same institution and completed their Master's degree in Medical Engineering between 2009 and 2013.

In 2012, Marco also took part in an Erasmus program at the Universidade Católica Portuguesa, although the specific field of study during this time is not provided.

Most recently, Marco has been attending the University of Rome Tor Vergata again, focusing on Ingegneria biomedica/medica. The exact duration of this program is not specified.

In addition to their formal education, Marco has also acquired several certifications to enhance their knowledge and skills. These include a Lean Six Sigma Green Belt Certification and an FMEA Specialist Certification, both obtained from the Advanced Innovation Group Pro Excellence (AIGPE™) in 2022. In 2020, Marco completed various courses through the Udemy Academy, including AIAG-VDA FMEA Training, Advanced Medical Device Development: TEST METHOD VALIDATION, Process Capability Analysis, and Statistical Process Control (SPC) Using Microsoft Excel. Other certifications include FORMAZIONE SPECIFICA OBBLIGATORIA LAVORATORI: LAB. ENGINEER from Microcosmo Consulenze in 2018, a Project Management Course from PQE Group in 2017, Il Fascicolo Tecnico - tempistiche e modalità di raccolta e gestione della documentazione per la marcatura CE di un Dispositivo Medico from Life Science Academy in 2016, and SolidWorks - Primo Livello from TeamSystem - Nuovamacut in 2011.

Links

Timeline

  • MD Compliance Manager

    January, 2021 - present

  • Senior Validation Engineer

    September, 2018

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