Post Market Quality Specialist

3 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), a groundbreaking therapy that measures the spinal cord's response to stimulation and makes real-time adjustments. As a Post-Market Quality Specialist, you will play a crucial role in ensuring the quality and safety of our medical devices.

Key Responsibilities
  • Evaluate and complete regulatory assessments and adverse event reporting for complaints and feedback, supporting all geographies
  • Manage complaint and feedback files, including timely intake and closure
  • Handle additional information requests, device returns, and Complaint Response Letters
  • Provide data inputs and analysis as needed, including monthly metrics, product trending, and regulatory agency requests
  • Communicate professionally with external parties, including end users, while maintaining HIPAA compliance
  • Maintain and support record retention and audit readiness processes
  • Participate in broader Quality Management System (QMS) initiatives and projects, including CAPAs and NCRs, when required
  • Drive efficiencies and process improvements for the Quality organization and cross-functionally, including frequent interaction with Supplier Quality and Customer Service
Requirements
  • Bachelor's degree in engineering, science, technology, or health, or 2+ years' experience in the medical device industry or a similar regulated environment
  • Strong attention to detail, preferably with knowledge of ISO 13485 Quality Management System, database entry skills, and good documentation practices
  • Excellent verbal communication and technical writing skills
  • Individual contributor with demonstrated organization and time management skills
  • Strong aptitude for learning technical concepts
  • Strong analytical and decision-making skills
  • Hybrid schedule, working out of the Bloomington-MN office


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