Michelle Frankfort
About Michelle Frankfort
Michelle Frankfort is the Design Quality Assurance Manager at Boston Scientific, with over a decade of experience in medical device quality assurance.
Company
Michelle Frankfort currently works at Boston Scientific, a global company known for its medical devices. Based in Marlborough, Massachusetts, her role involves ensuring compliance with various regulatory standards. She has worked with Boston Scientific in multiple positions since 2013.
Title
Michelle Frankfort holds the title of Design Quality Assurance Manager at Boston Scientific. Her role focuses on maintaining the quality and regulatory compliance of the company's products, particularly in the endoscopy portfolio.
Education and Expertise
Michelle Frankfort completed her Master of Business Administration (M.B.A.) at the University of Massachusetts Lowell, achieving a GPA of 3.99. She also holds a Bachelor of Science in Biomedical Engineering from Worcester Polytechnic Institute. Her educational background supports her extensive expertise in quality assurance and regulatory compliance for medical devices.
Professional Background
Michelle Frankfort's career at Boston Scientific spans several roles, starting as a Supplier Quality Engineer I in 2013. She advanced through positions including Supplier Quality Engineer II, EDGE Rotation Program roles, and various design quality assurance engineering positions. These roles have collectively contributed to her current position as Design Quality Assurance Manager.
Quality Assurance and Regulatory Compliance
Michelle Frankfort's career has a strong focus on quality assurance and regulatory compliance. She is responsible for ensuring the compliance of Boston Scientific's endoscopy portfolio with the latest Risk Management standard (ISO 14971:2019) and EU MDR. Her extensive experience includes transitioning medical device products to meet these new regulatory standards.