Complaint Handling Specialist Post Market
irhythm technologies, inc.
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.
Vacancy posted 1 day ago
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