Jae Seo

About Jae Seo

Quality Professional with over 10 years of experience in Quality Systems, Management Controls, New Product Development, Manufacturing Support, Process Validation, Complaint Investigation, and Supplier Management in FDA regulated industry.Wide range of experiences in Quality System including establishing a new Quality System at a start-up division as well as remediating existing Quality Systems in a multinational corporation.

Experience

1. Associate Director, Supplier Quality Management

   Bayer

   Jan 2017 — Present

   Supplier Management overseeing quality and compliance of numerous contract manufacturers/suppliers including Pharmaceuticals, OTC, and Medical Devices. Including several contract manufacturers with supply chains based out of the China and Southeast Asia-Overseeing and driving the transition of the North American Consumer Care organization to support the launch and post market sustaining activities for Class II Medical Devices, Class I Sterile Devices, and related integration of FDA Medical Device Quality System

Education

• Cornell University

  BS, Chemical Engineering

  1999 — 2003

• Cornell University

  MS, Chemical Engineering

  2003 — 2004

Skills

• Quality System
• V&V
• Statistical Process Control (Spc)
• U.s. Food and Drug Administration (Fda)
• Minitab
• Verification and Validation (V&V)
• Design of Experiments
• Manufacturing
• Fda
• Research and Development (R&D)
• Six Sigma
• Lean Manufacturing
• Iso 13485
• Medical Devices
• Capa
• R&D
• Validation
• Design Control
• 21 Cfr Part 11
• Root Cause Analysis
• Corrective and Preventive Action (Capa)
• Spc