Contact Information

Biography

Frank J. Falcione, Director of Quality and Regulatory, joined ChemImage in December 2021 with extensive experience in FDA submissions and ISO/FDA quality system implementation. At ChemImage, he is responsible for defining Quality and Regulatory strategies including milestone deliverables, budgets and staffing required to accomplish performance business and technical objectives. Immediately prior to joining ChemImage, Mr. Falcione was the Senior Vice President of Regulatory Affairs and Quality Assurance for ALung Technologies focused on assessing company goals through business process improvements, gap analysis and remediation activities in the areas of product development, quality systems, supply chain/supplier management, regulatory compliance (FDA, ISO, CE etc.) and manufacturing.

Prior to ALung, Mr. Falcione was the Vice President of Technologies for CHS Business Associates a consultant organization focused on assisting companies (start-ups to multibillion dollar companies) to meet and exceed goals. Prior to consulting, Mr. Falcione was the Director of Strategic Quality at Emerson where his responsibilities included the development, direction, and management of quality/engineering following North American organizational function: Product Integrity/ Reliability, Test Engineering, Quality System, Environmental, Global Supplier Quality and Quality Engineering. During his tenure, product and field reliability performance was increased by 70% within 18 months, and TL9000 was successfully achieved under a common registrar for all facilities. Prior to Emerson, Mr. Falcione held senior positions at Chiron Diagnostics and Ferranti Defense Systems, Inc.

Mr. Falcione earned his B.S. in Electronics Engineering from Pennsylvania State University and his EMBA, Business, from Baldwin-Wallace College.

Education

  • B.S. in Electronics Engineering,  Pennsylvania State University
  • EMBA in Business, Baldwin-Wallace College.

Industry Experience

  • Product Integrity/ Reliability,
  • Test Engineering,
  • Quality System, Environmental, Global Supplier Quality and Quality Engineering
  • FDA submissions and ISO/FDA quality system implementation
  • Defining Quality and Regulatory strategies- including milestone deliverables, budgets and staffing required to accomplish performance business and technical objectives.
  • Senior Vice President of Regulatory Affairs and Quality Assurance for ALung Technologies- focused on assessing company goals through business process improvements, gap analysis and remediation activities in the areas of product development, quality systems, supply chain/supplier management, regulatory compliance (FDA, ISO, CE etc.) and manufacturing.

Courses Taught

  • BTGY 504 Regulatory Aspects of the Development of Medical Products
  • BTGY 509 Biotechnology Product Development