Post Market Quality Specialist

4 weeks ago


Minneapolis, Minnesota, United States Saluda Medical Full time
Job Overview

Saluda Medical is a pioneering company in the field of closed-loop Spinal Cord Stimulation (SCS). As a Post-Market Quality Specialist, you will play a crucial role in ensuring the quality and compliance of our medical devices.

Key Responsibilities:

  • Evaluate and complete regulatory assessments and adverse event reporting for complaints and feedback
  • Manage complaint and feedback files, including timely intake and closure
  • Support additional information requests, device returns, and Complaint Response Letters
  • Provide data inputs and analysis as needed, including monthly metrics and regulatory agency requests
  • Communicate professionally with external parties, including end users
  • Maintain record retention and audit readiness processes
  • Participate in broader Quality Management System (QMS) initiatives and projects

Requirements:

  • Bachelor's degree in engineering, science, technology, or health
  • 2+ years' experience in the medical device industry or similar regulated environment
  • Strong attention to detail and knowledge of ISO 13485 Quality Management System
  • Strong verbal communication and technical writing skills
  • Individual contributor with organization and time management skills
  • Strong aptitude for learning technical concepts
  • Strong analytical and decision-making skills


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