Valrico, Florida, United States
Quality and Regulatory Engineering leader with over 10 years of experience in the medical device and consumer electronics space.
Ownership of development, execution, and maintenance of the Company Quality Management System.
Responsible for maintaining and continuously evolving the Quality Management System, while ensuring all relevant Internal and External standards and regulations are met.
Sole engineering support for 4 different processes within the Surgical Device franchise. Provide root cause analysis, problem solving techniques, and effective utilization of NC/CAPA system to prevent and control future processing issues. Continuous process quality monitoring, improvement, and development for all raw device inventory in Surgical franchise. Implementation of collection, storage, and manufacturing processes for existing and new products. Quality ownership of all operating procedures related to pre-process for surgical devices. Co-site lead for development, training, and implementation of Sentinel(Continuous Improvement) program for both Surgical and Non-Invasive franchise. Trained entire support stuff on effective Sentinel incorporation and design and launched tools and strategies into Non-Invasive franchise.
Management, Support, and Lean Coordination of Front End Associates