MARK BMark Bienkowski
Global Manager, Supplier Quality Process and Audits


As the Supplier Quality Process and Audits Manager, Mark is responsible for the GE Healthcare global purchasing controls systems and compliance. He also leads teams of Process Lean Leaders and Supplier Auditors who ensure clear and concise quality collaboration between GE Healthcare and its supply base. Mark also has experience in information technology, manufacturing engineering, new product development, and quality assurance.


Mark will be one of the distinguished speakers at the 2nd Annual Medical Device Supplier Quality Conference.


Why is the 2nd Annual Medical Device Supplier Quality Conference important to quality executives?
To share best practices, lessons learned, and better understand current regulatory trends.


What initiatives are on the horizon at your organization for supplier quality in 2015?
Improved supplier rating metrics, visibility, and analytics.


How has supplier quality evolved in the last several years?
With the increase in outsourcing more responsibility and risk control has been required from supplier quality. The FDA has noticed this outsourcing shift and have adjusted their audit focus to dive deeper into purchasing controls.


What are three or more key components that every quality agreement should have?
Supplier QMS, change control, quality record retention, post-market responsibilities, and audit rights.


What is one successful communication strategy you have implemented with suppliers?
Online access to our Supplier Quality System.


Can you describe a supplier development initiative that has been mutually beneficial for your supplier and your organization?
Supplier Lean / Kaizen Workouts at the supplier sites.