Steven Despot
- Role
- Senior Quality Engineer at Philips
- Location
- Pittsburgh, PA, US
- LinkedIn followers
- 500 followers
About Steven Despot
Accomplished Senior Quality Engineer with 18 years of experience across pharmaceutical…
Experience
Senior Quality Engineer
Aug 2021 — Present · Pittsburgh, PA, US
Demonstrate exemplary leadership in driving CAPA activities, from issue identification to closure, utilizing strong project management skills to ensure the quality and completeness of CAPA records, while effectively representing CAPAs during audits and CAPA Review Board meetings.\\\\n• Proficiently facilitate end-to-end product and process Corrective and Preventive Action (CAPA) investigations, expertly guiding the identification of issues, implementing robust solutions, and monitoring their effectiveness to achieve sustainable improvements.\\\\n• Take charge of project managing all aspects of CAPA activities, securing the commitment of cross-functional resources, efficiently scheduling CAPA team meetings, and ensuring on-time delivery of CAPA deliverables as per project timelines.\\\\n• Utilize advanced statistical techniques to meticulously analyze quality monitoring data sources, promptly identifying existing and potential causes of non-conformances, fostering a proactive approach to quality improvement.\\\\n• Effectively collaborate with all levels of management, ensuring that CAPA action plans receive adequate support, and the necessary costs/resources are available for successful plan implementation.\\\\n• Exhibit a deep understanding and application of global medical device regulations, standards, and requirements, encompassing FDA’s 21 CFR 820, ISO 13485, EU Medical Device Directive (93/42/EEC), ISO 14971, ISO 9001, and others, including expertise in the European Medical Device Regulation MDR 2017/745.\\\\n• Proven track record of success as an experienced engineer, effectively contributing to cross-sector or business process standardization to enhance efficiency and effectiveness while ensuring strict compliance with worldwide regulations.\\\\n• Exceptional communication skills, adeptly conveying and educating teams at all levels of the organization on Quality Management System regulations, policies, and strategies, fostering a culture of compliance and excellence.\\\\n \\\\n\\\\n \\\\n \\\\n\\\\n \\\\n
Education
Bethlehem-Center Senior High School
High School Diploma, General Studies
West Virginia University
Executive MBA, Business Administration and Management, General
2023 — 2025
West Virginia University
Bachelor of Arts - BA, Biology/Biological Sciences, General
2001 — 2006
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