Team

Mark Krutyholowa

Consultant

With over 20 years in the Combination Medical Device, Pharmaceutical, and Life Sciences industries, Mark Krutyholowa’ s career has spanned the development and launch of innovative combination products and processes. He has organized, led, and managed high-performing teams. His experience has enabled him to develop strategic, tactical, and action-based programs and roadmaps.  Mark is experienced in remediation of combination products ensuring compliance with FDA design controls. Mark’s unique ability to deliver stems from his broad use of six sigma, design for six sigma, design for reliability, robust design, lean, risk analysis, Industrial DOE, and QbD.

Academic & Professional Qualifications:
  • B.S. Materials Science and Engineering, University of Cincinnati
  • M.S. Material Science, Colorado School of Mines
Training, Quality Systems, & Specialties:
  • Six Sigma Black Belt Certified.
  • Design for Six Sigma Black Belt Certified.
  • Lean Certification
  • ISO 13485
  • ISO 11608
  • Design Control and Project/Program Management
  • Organization Efficiencies and Engineering Core Competencies
  • Product and Process Development
  • Design Control Remediation
  • Reliability for Emergency Use Devices