Caleb Jung

About Caleb Jung

High-performing, strategic-thinking professional with more than seventeen years of experience in continuous improvement. Expatriate experience for an off-shore manufacturer in Asia. Experienced at managing a diverse team for product lifecycles from design concept to manufacturing. Highly skilled at relationship-building across organizations and diverse cross-functional teams; exceptional writing, presenting, and interpersonal communication skills. c••••••••@gmail.com

Experience

1. Director of Global Quality Compliance

   Merz Aesthetics

   Jul 2023 — Present · WI, US

   Ensure Compliance of the Global Quality Management System (QMS) to the most current version of applicable International Medical Product (Device, Rx, OTC, Biologic) Regulations and Standards through effective implementation, training, and monitoring- Establish and manage Global Internal and External Audit Programs including Interface with external agencies as required including the FDA and the Notified Body - Partner with Global Regulatory Affairs to assure integration of Regulatory Intelligence activities and changing expectations into the QMS- Develop company-wide Quality compliance roadmap and define priorities in line with global requirements and existing compliance gaps including the development, installation and monitoring of Global Quality Policies and Procedures- Define global processes & collaborate with the site Quality Heads to ensure execution on site level, supporting the site leaders as needed - Harmonize the quality compliance standards and ensure they are aligned across functions- Collaborate with Global Site Quality Leaders to establish and execute digital strategies for Global Quality and Compliance Data - Facilitate Global Quality Management Review for the Global Leadership Team - Establish a global system for routine review of quality system data, including internal/external audit results to determine compliance gaps and associated mitigation plans on a global level- Define, implement, and improve tracking mechanism for compliance progress - Allocates human resources and selects, acquires, and deploys appropriate methodologies to fulfill near term goals and commitments while ensuring sustainable quality performance- Motivates and leads their organization to achieve business objectives

Education

• University of Wisconsin-Madison

  MBA

  2015 — 2017

Skills

• Fda
• Design Control
• Medical Devices
• Capa
• Gmp
• Quality System
• V&V
• Validation
• Quality Management
• Dmaic
• Leadership
• Quality Assurance
• Process Improvement
• Cross-Functional Team Leadership
• Iso 14971
• Six Sigma
• Quality Auditing
• Iec 62304
• Iso 13485