[Remote] Quality Specialist-Post Market
Note: The job is a remote job and is open to candidates in USA. iRhythm Technologies, Inc. is a leading digital healthcare company that creates trusted solutions for cardiac health. The Quality Specialist-Post Market role involves evaluating and investigating product complaints, maintaining logs, and ensuring compliance with regulatory requirements.
Responsibilities
- 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
- Evaluate all information from a technical perspective to ensure appropriate analysis and investigation is complete
- Ensures issues are being addressed and escalated in a timely manner
- Maintains complaints log
- Participates in process improvements
- Perform other quality and regulatory-related duties as assigned
Skills
- Must work across functional teams within the organization and seek input from Product Quality, Product Development Engineers, and other departments for complaint investigation
- Identify problems and lead projects to improve processes, procedures and/or practices; recommend and resolve solutions
- Excellent communication (verbal and written) and interpersonal skills required
- Demonstrated experience with MS Word, Excel, Adobe Acrobat, and other commonly used software systems
- Basic knowledge of Quality Systems (CAPA/non-conformances/SCARS) a plus
- 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
Company Overview
Company H1B Sponsorship