David Bowie

Experience

1. Quality Engineer

   BD

   Jan 2016 — Present

   Perform in-depth Root Cause Analysis of non-conforming product and processes using various quality tools • Initiate exception reports, investigate complaints and product failures in the field, and implement associated corrections, corrective actions, and preventive actions • Collaborate with Operations/ Manufacturing Engineering to sustain the yield of the various manufacturing lines, resolve issues relating to the quality of the product, and provide training and engineering support to operators by making decisions regarding product disposition • Interface with Production, Manufacturing Engineering, R&D, and Regulatory departments in continuous improvement projects to maximize the quality and flow of product through the various manufacturing lines • Participate in capturing quality metric data for analyzing methods to enhance sustaining product design as part of the Corrective Action Board (CAB)

Skills

• Product Launch
• Corrective and Preventive Action (Capa)
• Root Cause Analysis
• Quality Assurance
• U.s. Title 21 Cfr Part 11 Regulation
• Iso 13485
• Microsoft Office
• Medical Device R&D
• Cross-Functional Team Leadership
• Customer Service
• Quality Control
• Business Development
• Risk Management
• Team Management
• Verification and Validation (V&V)
• Research and Development (R&D)
• Continuous Improvement
• Product Management
• Medical Devices
• Standard Operating Procedure (Sop)
• Manufacturing
• Leadership
• Fda Gmp
• U.s. Food and Drug Administration (Fda)