[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 will be responsible for receiving, processing, analyzing, and reporting product complaints, as well as developing and updating company procedures to ensure 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