George Papcun

About George Papcun

Personal Overview:Highly driven quality professional with over 28 years of progressive medical device quality engineering, product lifecycle/configuration management, manufacturing, regulatory compliance, project, program, and functional management experience. Solid track record of delivering outstanding business results through a successful combination of emotional intelligence (EQ), technical leadership, customer focus, problem-solving, risk-based decision making, collaboration, trust building, and lifelong learning.Key Responsibilities:• Defining and implementing the Product Lifecycle Management (PLM) vision and future capabilities roadmap for the Radiology business unit within the Bayer Pharmaceuticals Division• Deploying and managing Radiology\'s PLM enterprise software solution across global Bayer supply centers located in the US, Australia, Costa Rica, and China• Leading the PLM Change Advisory Board (PLM CAB) • Aligning people, processes, technology, and data around the CM2 model• Transitioning the organization from a document-centric to a data-centric PLM methodology (e.g, eBOM, mBOM, eDHF, eDMR, etc.)• Providing direction to the Radiology Devices Configuration Management (CM) team and serving as PLM Business Process & Data Owner• Driving efficiency and efficacy improvements within the Change Management process and through CM standardization• Serving as a quality and PLM/CM subject matter expert (SME) during internal and external compliance audits and inspections (e.g. FDA, MDSAP, BSI)Areas of Interest:• CM / PLM / ALM (Application Lifecycle Mgmt.)• Data Integrity / Strategy / Governance / Quality• Industry 4.0 / Quality 4.0• Applied Data Science / Analytics• Computer Software Assurance (CSA)• Risk ManagementOrganizations:• International CM2 Congress (IpX)- Executive Operations Officer • American Society for Quality (ASQ)- Senior Member• MedTech Customer Advisory Board (PTC)- Member

Experience

1. Director, Radiology Configuration Management

   Bayer

   Apr 2025 — Present

Education

• California State University-Dominguez Hills

  Master of Science (MS), Quality Assurance: Manufacturing

• University of Maryland

  Bachelor of Science (BS), Electrical Engineering

• Community College of Allegheny County

  Associate in Science (AS), Physics