Gus Rathgeber is currently the Director of Supplier Quality and Vascular Products for DJO Global located in Vista, CA. Gus has more than 30 years of diverse experience as a Quality Assurance practitioner with more than 10 years in Supplier Quality Leadership.
Gus 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?
For keeping up to date with latest trends in Quality/Regulatory practices.
What initiatives are on the horizon at your organization for supplier quality in 2015?
We are deploying a standardization strategy for ensuring supplier compliance. The approach is scalable to the diverse supply chain we engage ensuring equitable treatment of all issues.
How has supplier quality evolved in the last several years?
It has become much more focused on global strategies and sensitized to international regulations. The greatest challenge in Supplier Quality has been resource limitations for assurance of compliance. Greater dependency on supplier’s goodwill.
What are three key components that every quality agreement should have?
Clarity of expectations, negotiated requirements, and consequences of failure to comply.
What is one successful communication strategy you have implemented with suppliers?
Web-based third-party platforms that compliment traditional face-to-face communication.
Can you describe a supplier development initiative that has been mutually beneficial for your supplier and your organization?
In every situation where the direct supplier is having difficulty with a sub-tier supplier we have leveraged the power of two or the scope of knowledge creating alternative solutions for the direct supplier to employ.
How do you believe FDA expectations have changed with regards to supplier quality?
Much more invasive. Traceability and identification requirements are causing a greater need for supplier oversight and process insight.
Any other comments you would like to include about your recent experiences with supplier quality?
The manufacturing industry is becoming more specialized whereby device “manufacturers” are now “integrators.” That said, cost effective procurement strategies involve a greater expanse of suppliers providing critical components increasing the need for early engaging suppliers earlier in the device design phase.