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
iRhythm is a leading digital health care company that creates trusted solutions that detect, predict, and prevent disease. It was founded in 2006, and is headquartered in San Francisco, California, USA, with a workforce of 1001-5000 employees. Its website is http://www.irhythmtech.com.Company H1B Sponsorship
iRhythm Technologies, Inc. has a track record of offering H1B sponsorships, with 9 in 2025, 13 in 2024, 10 in 2023, 9 in 2022, 16 in 2021, 11 in 2020. Please note that this does not guarantee sponsorship for this specific role.
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