About Susanne Manz
Susanne is an accomplished leader with over 30 years experience at leading companies such as  Johnson and Johnson, Medtronic, and GE.  She combines a technical education in Biomedical Engineering with outstanding knowledge of medical device regulations. She has a proven track record in quality and compliance. 
Susanne has experience in all phases of the product life cycle from design and development, to manufacturing, to post market activities.  She is experienced in dealing with the FDA and other regulatory bodies and has resolved many compliance issues.
Susanne has a passion for lean sigma demonstrated by her certification as a Master Blackbelt.  Susanne utilizes six sigma tools to create data driven, practical, and lasting solutions.
  • BS Biomedical Engineering - UNM Presidential Scholar
  • MBA
  • Certified Blackbelt in Lean Sigma
  • Certified Master Blackbelt in Lean Sigma
  • US Patent for Predictive Indicator Model for Quality
  • ASQ Certified Quality Auditor
  • RAPS Regulatory Affairs Certification
  • ASQ International Team Excellence Judge
  • Speaker at multiple industry conferences

Susanne has conducted countless webinars, seminars, and customized training events on quality and compliance for medical device companies.

Susanne is author of Medical Device Quality Management Systems - Strategy and Techniques for Improving Efficieny and Effectiveness  published October of 2018 by Academic Press, an imprint of Elsevier.  
"Susanne brings world class knowledge and subject matter expertise  to all aspects of Quality, Regulatory and Compliance disciplines.  She has high integrity and has admirable people and process analysis skills.  Her leadership capabilities coupled with her pragmatic approach to problem solving using her wealth of knowledge in Six Sigma lend themselves to innovative and lasting process and quality system improvements.  She is a joy to work with and I would welcome the opportunity to work with her again on any project.  I  highly  recommend her to any organization in need of a reputable and knowledgable quality professional."
Pat Strong - Quality Assurance Professional/MBB