[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

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