[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 focused on cardiac health solutions. The Quality Specialist-Post Market will be responsible for receiving, processing, analyzing and reporting product complaints, as well as maintaining and analyzing problem logs to identify recurring issues.

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

• Bachelor's Degree or Associate Degree in science, technology or medical fields
• 3- 5 years of experience in Quality Assurance and / or a complaint processing role
• Strong problem-solving skills, critical-thinker, and experience at investigating and resolving complex issues
• Understand basic principles of good technical writing skills and be able to articulate findings and formulate conclusions
• 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
• Previous experience in medical devices with working knowledge of ISO 13485, FDA 21 CFR 820, European Union MDD /MDR is an asset
• Basic knowledge of Quality Systems (CAPA/non-conformances/SCARS) a plus
• 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 7 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.