Principal Quality Systems Specialist
Why is the quality management system within the medical device industry important?
There is the perception that a QMS is simply a list of documented processes and work instructions. However, it is about understanding the interrelationships of these defined processes that span across all function, and because they are documented and measurable, this results in objective evidence to determine how to reach the organization’s performance goals and customer requirements – which includes everyone from regulators to patients.
How do you see the quality management system role evolving over the next 5 years?
I am excited to see the QMS evolving from a Quality function that is perceived as a set of compliance requirements to one that also has commitment from senior leadership in all functions to allow for the company to have a QMS that is not only robust, but also efficient, flexible and strategic in a regulatory environment that is constantly changing.
What has been your greatest achievement within your current role?
There were many challenges in this role, including the development of QMS that would not only be in compliance to the regulatory requirements but also alignment to the Corporate’s long term strategy and in harmony with the sister sites globally. One of the greatest achievements was building a systematic and detailed approach for how to handle FDA inspections which we called the “Inspection Readiness Program.” This program was piloted and went through multiple simulations and process improvements, the need for creative methods for increasing employee engagement, continued financial and strategic support from senior leadership, and ultimately the execution of this program, when the FDA came in unannounced. The creation and execution of the FDA Readiness Program ensured a systematic approach that minimized the uncertainty in a highly stressful environment, a team effort to the end line, and a strategic and highly engaged leadership when it came time to address the 483s that were issued.
What are you most looking forward to regarding the Medical Device Quality Management System Conference?
Being able to engage in conversations to determine best practices and understand the various challenges that others face in their roles and strategies taken to address those challenges in an ever changing regulatory environment for medical devices. I am excited and look forward to these exchange of ideas!
Shilpa will be one of the distinguished speakers at the Medical Device Quality Management Systems Conference.