Team

Glenn Empey

Sr. Principal Consultant

Glenn has over 30+ years of device development experience in regulated medical devices at multiple global companies and is considered an experienced team leader with strong people skills. He has a strong track record of successful design and development management, manufacturing process development, and effective design transfer, with practical experience in Project Management, Development Engineering, Engineering Management, Quality Systems, Regulatory affairs, Risk Management, and Quality Assurance. Glenn’s working knowledge also includes Mechanical Engineering, Manufacturing Process Development, Facilities Management, and Clinical Development.

Academic & Professional Qualifications:
  • S. Mechanical Engineering, ITT Technical Institute
  • ASQ Six Sigma Black Belt
Training, Quality Systems, & Specialties:
  • Design & Development/Engineering
  • Regulatory Affairs/Submissions/Strategy
  • Quality Engineering
  • ISO 13485
  • ISO 14971
  • IEC 62366
  • ISO 11608
  • 21 CFR 820.30