Steven Despot

About Steven Despot

Accomplished Quality and Compliance professional with over 20 years of progressive…

Experience

1. Senior Quality Engineer (Capa Systems) Systems Design Quality

   Philips

   Aug 2021 — Present · Pittsburgh, PA, US

   QMS Local Lead Deployment PM for Project CAPA NextGen with Event Management and Analytics• Global Quality Compliance CRB Chair Delegate. Transformed the business compliance communication program within three months, evolving it from overdue items/reassessments to prioritized quality. Led two previously lagging QMS entities to become exemplars of excellence, positioning the program as a leader among Philips businesses.• Managed day-to-day CAPA activities as well as remediation activities required by FDA consent decree.• Managed CAPA activities, securing cross-functional resources, scheduling efficient team meetings, and ensuring on-time project delivery, resulting in a significant reduction of the CAPA backlog by over 50% within three quarters.• Collaborated with Philips global experts in Pittsburgh and Boston in 2024 to support the worldwide deployment of Appian as an advanced CAPA management solution. Performed PQ testing to ensure its timely deployment.• Utilized advanced statistical techniques to analyze quality monitoring data, promptly identifying causes of non-conformances, and fostering a proactive approach to quality improvement.• Collaborated with all levels of management, ensuring CAPA action plans received adequate support and necessary resources for successful implementation.• Provided my insight and experience to emphasize that a consistent CAPA approach exists across the organization while maintaining compliance to the regulatory requirements and associated GxP guidelines and regulations.• Interview and onboard new associates to ensure they are engaged and have support in their early stages within the organization. Provide guidance and direction with open communication maintained throughout.• Interact with internal and external auditors as part of consent decree initiatives to explain the process workflows and records.

Education

• Bethlehem-Center Senior High School

  High School Diploma, General Studies

• West Virginia University

  Master of Business Administration - MBA, Business Administration and Management, General

• West Virginia University

  Bachelor of Arts - BA, Biology/Biological Sciences, General