Elie Ghattas

Experience

• 

  Biosense Webster

  Jan 2009 - now

  Established and standardized Product Issue Assessment and Field Corrective Action procedures across Cardiovascular Surgery and Specialty Group to ensure compliance with FDA regulations, ISO standards, and Johnson & Johnson standards and policies. Supervised 3 direct reports and managed budget of approximately $4M. Remained involved in product quality and impact.• Created 3-tiered escalation process (trigger, review, action) for identifying noncompliant or defective products and pulling them from market.• Developed and deployed end-to-end capabilities to streamline processes, improve reliability, and increase efficiency. Show less Responsible for documentation, training, labeling, change control, GxP system validation and PLM system. Managed team of admins who evaluated and reviewed change management system (PLM).• Digitized labeling process, replaced visual verification with computer verification, improving accuracy by 200%, increasing productivity by 70%, and reducing translation costs by 50%.• Improved training process to create curricula based on job descriptions instead of assignments. New curricula aligned job descriptions with job responsibilities. Show less

  • Senior Manager, Quality and Risk Management

    Jan 2018 - now

  • Manager, Risk Management

    Jan 2016 - Jan 2018

  • Senior Manager, Escalation and Field Action

    Jan 2014 - Jan 2016

  • Senior Manager, Worldwide Quality System

    Jan 2011 - Jan 2014

  • Project Manager, Microbiology

    Jan 2009 - Jan 2011