Mary McCombs-Stearnes


Principal Consultant

As a Principal Consultant, Mary brings more than 27 years of experience in regulated environments (FDA/ISO) to MRC Global. Her vast expertise includes research and development, quality, sourcing and project management across multiple industries including medical device, automotive and consumer goods.

She has a proven track record of developing and executing robust and highly complex programs in collaboration with a cross functional and multi-cultural team. This includes product portfolio development with KOLs, procurement excellence transfers, brand rationalization, material qualification, acquisition integration, device history file remediation and product life cycle management. 

As an executive leader, Mary has held several director level roles throughout her accomplished career where she was responsible for strategic business development, product development and deployment, quality assurance and compliance, risk management, technology implementation and much more.

Mary holds a Master of Science in Industrial Engineering with a focus in Engineering Management from Western Michigan University and a Bachelor of Science in Mechanical Engineering from Calvin College. Her depth of experience and industry knowledge has enabled her to create and patent four medical devices with several currently in submission.

  • BSME with 25 plus years of design and development engineering experience
  • Director of Engineering with more than 15 years in R&D, Quality and Manufacturing Transfer for Wright Medical and Stryker
  • Experienced in project management, quality and operations engineering support for NPI and sustaining product lines
  • Masters in Industrial Engineering specializing in Engineering Management