Job Description
About This Role:
- Acts as primary notification and consolidation point for receiving, processing, analyzing and reporting product complaints.
- Develops and updates company complaint and inspection procedures to ensure capture and investigation of complaints.
- Maintains and analyzes problem logs to identify and report recurring issues to quality assurance management and product development.
What You Will Be Doing:
- Evaluates complaints to determine reportability in accordance with 21 CFR Part 803 Medical Device Reporting, European Vigilance Reporting, etc.
- Performs and/or coordinates complaint investigations and gathering of additional information.
- Ensures issues are being addressed and escalated in a timely manner.
Ways to Stand Out:
- Must be able to work under minimum supervision and in a team environment.
- Must be a positive and energetic team player.
- Experience with software/firmware complaints a plus
About IRhythm Technologies
iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information.