LEE-YOUNGLee Young
Director, Supplier Quality
THERMO FISHER SCIENTIFIC

 

Lee has 25 years of supplier quality experience with companies like Intel, Carefusion, and L-3 Communication. Lee sits on the advisory council for the University of San Diego. He graduated from the University of Arizona with a bachelors in Chemical Engineering.

 

Lee 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? 
One of the best ways to stay connected to the rapidly changing industry.

 

What initiatives are on the horizon at your organization for supplier quality in 2015?
Risk management on a worldwide scale. Globalization across 540 sites supporting supplier quality.

 

How has supplier quality evolved in the last several years?  
More involvement with 2nd and 3rd tier suppliers.

 

What are three key components that every quality agreement should have?
Change control and notification, complaint handling (CAPA control), and traceability.

 

Can you describe a supplier development initiative that has been mutually beneficial for your supplier and your organization?
Supplier partnership program for strategic vendors which allow them early access to our designs and allows us to use existing vendors.

 

How do you believe FDA expectations have changed with regards to supplier quality?
Yes, more supplier controls.

 

Any other comments you would like to include about your recent experiences with supplier quality?
2015 will be an extremely exciting year!