Shawn Kim

Experience

1. Quality Manager

   Ablative Solutions

   Apr 2019 — Present

   Support production activities at contract manufacturers through daily quality engineering support, process validations, test method validations, and production verification activities • Managing and improving the Supplier Management System, including implementing electronic system for supplier management and supplier control activities • Collaborate with R&D and Operations for qualification of new contract manufacturer based in Ireland • Support VP of Quality in quality systems & assurance tasks, such as internal audits, CAPAs, Supplier CAPAs, management review, document control, and training • Administrator of Grand Avenue software system for document control, training, and supplier management modules. • Responsible for managing and improving quality assurance procedures such as Risk Management, Statistical Techniques, CAPAs, NCRs, Process Validations, etc.

Skills

• Supply Management
• Quality Engineering
• V&V
• Design of Experiments
• Medical Devices
• Auditing
• Iso Standards
• U.s. Food and Drug Administration (Fda)
• Iso 13485
• Quality Systems
• Cqa
• Supplier Management
• Risk Management
• Fmea
• Design Control
• Root Cause Analysis
• Capa
• Iso 14971
• Quality Control
• Fda
• Validation
• Supplier Quality
• Solidworks
• Quality System