Post-Market Complaint & Quality Investigator

iRhythm Technologies, Inc.; Metro Manila; On-site; PHP 420,000 - 600,000; Full time

Benefits offered by this job

Equal Opportunity Employer

Accommodations for disabilities

Job summary

iRhythm Technologies, Inc. in Manila is seeking a Complaint Handling Specialist to manage intake, evaluation, and closure of product complaints in compliance with ISO 13485, 21 CFR 820.198, and EU MDR.

You will coordinate detailed investigations with Quality Engineering, Manufacturing, and R&D teams, ensuring proper documentation in the eQMS and timely, accurate processing while focusing on patient safety and product quality.

Qualifications

• Experience handling consumer/product complaints in a regulated environment.
• Ability to investigate root causes and determine corrective actions.
• Strong documentation and data accuracy to meet regulatory standards.

Responsibilities

• Manage intake, evaluation, investigation, documentation, and closure of complaints.
• Review information for completeness, accuracy, and classification (reportable vs non-reportable).
• Coordinate with Quality Engineering, Manufacturing, and R&D for investigations and CAPAs.
• Ensure complaint records are documented in eQMS and comply with ISO 13485, 21 CFR 820.198, EU MDR.

Skills

Complaint handling

Root cause analysis

Documentation

Cross-functional collaboration

Tools

eQMS

Job description

iRhythm Technologies, Inc. in Manila is seeking a Complaint Handling Specialist to manage intake, evaluation, and closure of product complaints in compliance with ISO 13485, 21 CFR 820.198, and EU MDR.

You will coordinate detailed investigations with Quality Engineering, Manufacturing, and R&D teams, ensuring proper documentation in the eQMS and timely, accurate processing while focusing on patient safety and product quality.