Complaint Handling Engineer

7 days ago

Pune, India Tata Elxsi Limited Full time

Job Description

Key Responsibilities:

- Handle end-to-end complaint processing including intake, triage, product detail capture, decision tree handling, and closure
- Perform vigilance reporting and handle IMDRF and FDA coding activities
- Conduct complaint investigations and ensure due diligence in documentation
- Monitor and manage the complaint mailbox and coordinate follow-up communications
- Evaluate incoming complaints and accurately log data in the electronic system
- Perform follow-up for additional complaint information and trend analysis
- Determine the reportability of complaints and submit required reports to regulatory bodies
- Classify and document complaint categories for accurate trending
- Write concise investigation summaries based on technical findings
- Prepare and submit MedWatch-3500A, MIR Reports, and all required regulatory submissions within timelines
- Conduct coding of complaints and maintain accuracy and consistency
- Ensure all complaint investigations meet MDR, FDA, and internal SOP requirements
- Monitor and understand KPIs related to complaint handling
- Escalate significant events in a timely manner to the Team Lead or Manager
- Perform quality control checks on all record types and related complaint documents
- Maintain audit-ready documentation at all times
- Liaise with internal teams including Technical Services, Manufacturing, R&D, and Quality Assurance for investigations
- Provide basic technical expertise to ensure compliance with FDA and international reporting requirements

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