Nirav Shah

Experience

• 

  Argon Medical Devices, Inc.

  Jan 2000 - Jan 2001

  QC Supervisor
• 

  Argon Medical Devices, Inc.

  Apr 2001 - Apr 2019

  Manage the continuous improvement program using Lean and Six Sigma techniques. Certified in Six Sigma Black Belt from University of Illinois. Manage Quality Control, Incoming Quality, Customer Complaints, Calibration, Preventive Maintenance and Metrology functions. Team member for Internal Audits, Supplier Audits, Material Review Board, Engineering Projects.Manage a team of 15 QC Inspectors and handle priorities and projects. Proficient in ISO 13485, FDA Part 820 Medical Devices, cGMP and cGLP, CAPA, Root Cause Analysis, FDA Audits.Trained in 5S and Lean Manufacturing.

  • Continuous Improvement Manager

    Aug 2015 - Apr 2019

  • Quality Assurance Supervisor

    Apr 2001 - Aug 2015
• 

  Surface Solutions Group

  Apr 2019 - now

  Director Of Quality