Post Market Quality Specialist

2 months ago


Minneapolis, United States Saluda Medical Full time
Job DescriptionJob DescriptionSalary:

Saluda Medical is the pioneer in closed-loop Spinal Cord Stimulation (SCS), a ground-breaking SCS therapy that can measure the spinal cord’s response to stimulation and make real-time adjustments to therapy. Saluda is a global company with headquarters in Australia and offices in the United States and Europe.

 

The Post-Market Quality Specialist is responsible for the processing and management of feedback and complaints. This role will also support Post-Market Quality data management and requests for broader QMS initiatives.

 

Accountabilities and Associated Responsibilities:


  • Evaluate and complete regulatory assessments and adverse event reporting for complaints and feedback, supporting all geographies
  • Complaint and Feedback file management, including timely complaint intake and file closure
  • Responsibility for additional information requests, device return and Complaint Response Letters
  • Provide data inputs and analysis as needed, including monthly metrics, product trending and regulatory agency requests
  • Conduct professional, HIPAA compliant communication to external parties, including end users
  • Maintain and support record retention and audit readiness processes
  • Participate in broader QMS initiatives and projects including supporting CAPAs and NCRs, when required
  • Drive efficiencies and process improvement for the Quality organization and cross-functionally, including frequent interaction with Supplier Quality and Customer Service

 

Essential Requirements:


  • Bachelor’s degree in engineering, science, technology or health OR 2+ years’ experience in the medical device industry or similar regulated environment
  • Strong attention to detail, preferably with knowledge of ISO 13485 Quality Management System, database entry skills and good documentation practices
  • Strong 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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