Complaint Handling Specialist - Post Market

iRhythm Technologies Inc.; Metro Manila; On-site; PHP 350,000 - 500,000; Full time

Job summary

iRhythm Technologies Inc. is seeking a Complaint Handling Specialist in the Philippines to oversee intake, evaluation, investigation, documentation, and closure of product complaints in line with regulatory requirements.

The role supports root cause analysis and drives corrective actions to improve product quality and patient safety, collaborating with Quality Engineering, Manufacturing, and R&D teams. The position emphasizes accurate logging in the eQMS, timely processing, and strict adherence

Responsibilities

• Receive, log, and acknowledge customer complaints within established timelines.
• Review complaint information for completeness, accuracy, and classification (e.g., reportable vs. non-reportable).
• Conduct detailed investigations, including root cause determination, in coordination with Quality Engineering, Manufacturing, and R&D teams.
• Ensure complaint records are properly documented in the electronic Quality Management System (eQMS).
• Maintain compliance with complaint handling procedures per ISO 13485, 21 CFR 820.198, and EU MDR.

Job description

Job Description

The Complaint Handling Specialist is responsible for the intake, evaluation, investigation, documentation, and closure of product complaints in compliance with internal procedures and regulatory requirements. This role ensures timely and accurate processing of complaints, supports root cause analysis, and collaborates with cross-functional teams to drive corrective and preventive actions that enhance product quality and patient safety.

Key Responsibilities

• Complaint Management
• Receive, log, and acknowledge customer complaints within established timelines.
• Review complaint information for completeness, accuracy, and classification (e.g., reportable vs. non-reportable).
• Conduct detailed investigations, including root cause determination, in coordination with Quality Engineering, Manufacturing, and R&D teams.
• Ensure complaint records are properly documented in the electronic Quality Management System (eQMS).
• Maintain compliance with complaint handling procedures per ISO 13485, 21 CFR 820.198, and EU MDR.