Carl Shubitowski

Carl Shubitowski has a diverse work experience in the field of quality and regulatory roles. Carl is currently working as the Director of Quality and Regulatory at AION Biosystems since January 2022. Before that, they served as a Quality Engineer at Becton Dickinson Company from May 2021 to May 2022. Prior to that, they worked as a Senior Quality Engineer at OmniGuide in April and May 2021. Carl also worked as a Principal Quality Engineer at Third Pole Therapeutics from February 2018 to January 2021.

In their previous roles, Carl held the position of QE Manager at Microline Surgical from December 2015 to November 2017, where they managed CAPA, non-compliances, complaints, document control, and incoming inspection. Carl successfully improved supplier quality and reduced incoming defects by 50%. Carl also played a crucial role in improving trending reporting and reducing the backlog of complaints in the company.

Furthermore, they served as a Quality Assurance Manager at Precision Engineered Products LLC (PEP) from March 2015 to November 2015, where they managed a team of incoming inspectors and a QE. Carl hosted notified body and supplier audits and worked closely with suppliers to enhance the company's quality.

Carl also worked at Boston Scientific as a Sr. Quality Systems Engineer from July 2014 to March 2015. In this role, they oversaw the integration of a start-up company's Quality System and CAPA program into Boston Scientific's system. Carl successfully migrated the paper system to an electronic system and managed the CAPA program.

Additionally, Carl worked as an Advanced Development Engineer at Siemens Healthcare from November 2013 to February 2014. Prior to that, they held the position of Principal Advanced Manufacturing Engineer at Stryker Medical from February 2011 to October 2013. In this role, they led the advanced manufacturing portion of a new hospital mattress launch, designed and installed a new hospital bed assembly line, and played a key role in bringing a manufacturing process and product back to Michigan.

Carl Shubitowski earned a Bachelor of Science in Chemical Engineering from the University of Michigan in 1989. Carl later obtained a Masters degree in Engineering with a focus on Sustainable Energy & Hybrid Technology from Kettering University from 2009 to 2012. In addition, they have several certifications in Python programming from Coursera, including "Python Data Representations," "Python Programming Essentials," "Programming for Everybody (Getting Started with Python)," and "An Introduction to Interactive Programming in Python."