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About us

Jane Keathley, MS, PMP is the Principal Consultant for Keathley and Company, LLC. Ms. Keathley is an accomplished professional with extensive experience in a variety of healthcare-related sectors, including medical device software, clinical research, pharmaceutical development, and diagnostic microbiology.

Areas of focus

  • Systems and innovation management
  • Product quality
  • Process management
  • Performance excellence

LinkedIn profile

Skills and Expertise

  • Expert knowledge in process definition and improvement across health-care related industries
  • Effective team leader and communicator, both written and oral
  • Certified Project Management Professional (PMP); strong project management skills; able to manage projects under tight timelines and across international and cross-functional teams
  • Trained Internal Auditor,completed training on FDA Quality System Regulations (Emergo), ISO9001 Standards (Excel Partnership, Inc), Value Stream Mapping (GenEdge)
  • Skilled compliance auditor for FDA regulations and ISO standards
  • Master of Science degree, Medical Microbiology; Bachelor of Science Degree, Medical Technology, Minor Chemistry

Career profile

  • Over 25 years’ experience directing quality management systems in medical device software development, clinical research, pharmaceutical development, and diagnostic laboratories
    • Principal Consultant since 2012, focused on effective and efficient operations in regulated industries, system integrations, and regulatory and technical writing in medical device software and clinical research areas
  • Regular presenter on quality and innovation topics
  • 2019-2020 Director, American Society for Quality (ASQ) Board; Co-Chair, ASQ Excellence and Performance Recognition Program
  • Member and Past (Founding) Chair, ASQ Innovation Technical Committee
  • Past Examiner for Baldrige Performance Excellence Program (national) and Virginia Senate Productivity and Quality Award Program (SPQA; state); examiner for performance submissions across all industry sectors; participated in multiple site visits
    • Served on SPQA Board of Directors and Training and Education Chair, 2014-2015
    • Served as Judge for Maryland Performance Excellence Award program, 2014-2015
  • Experienced internal and external compliance auditor for regulatory and ISO standards; coordinated internal teams for multiple audits by external clients, inspectors and registrars
  • Five-term Adjunct Faculty member teaching Medical Microbiology and Biology; also conducted multiple in-house training sessions on quality management systems, auditing, and regulations; SPQA Trainer for Baldrige Criteria and Examiner Training; multiple Innovation Management workshops