ShiraTronics Inc.

Key Requirements:

  • Minimum 15 yrs experience in leadership roles within the Quality function
  • Minimum 2 yrs experience in active implantable medical devices
  • BS/BA in Engineering, Life Sciences, or Business
  • Certified ISO 13485:2016 lead auditor
  • Previous experience in ISO 13485 certification process
  • Experience with FDA inspections and/or Notified Body assessments

Key Responsibilities:

  • Management of Supplier Quality Deliverables and Supplier Evaluation processes
  • Complete development of the company‚Äôs Quality Management System
  • Management Representative for the QMS
  • Serve as Quality representative on product development team
  • Build and maintain an effective Quality team
  • Lead ISO 13485:2016 certification effort
  • Company focal point for FDA inspections and Notified Body Assessments
  • Position currently reports to the Vice President, Regulatory Affairs and Quality Assurance

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