Associate Director of Quality
What has been your greatest achievement within your current role?
The quality system improvement initiatives that enable us to successfully resolve a warning letter. These improvements also led to a shift in the company’s culture to be more aware of the QSR requirements and why all employees are key to our continued success.
What advice would you give to QS professionals in their early career?
Obtain experience in numerous roles both within the quality organization as well as outside, such as: operations, manufacturing, etc. I believe this cross-functional experience not only provides you with an understanding of what other groups experience and deal with, but allows one to expand their approach to consider options “outside the box.” This enables the company to develop and determine best practices that comply with the Quality System Regulations and ISO requirements while supporting business needs.
What will be your key priorities in the next 6 months?
Implementation of QMS software tool to utilize an electronic solution instead of a manual process to manage Doc Control and Training. Evaluate processes for improvements to support business growth.
What are you most looking forward to regarding the Medical Device Quality Management System Conference?
How to best implement a risk-based approach throughout the quality system.
Lisa will be one of the distinguished speakers at the Medical Device Quality Management Systems Conference.