Complaint Handling Specialist

Overview

The Complaint Handling Specialist supports and coordinates the management of complaints within post-market surveillance operations, working under direct supervision and established processes.

What you'll do

• Provide information on basic product-specific concerns and support responses to questions from complaint evaluators and complaint investigators.
• Record the quality of the complaint handling process executed by complaint evaluators and complaint investigators, and assist in ongoing evaluation and improvement measures.
• Assist in reviewing basic complaints, identify instances requiring escalation (including initial coding assessment, product inquiries, and reportability decisions), and address routine product inquiries.
• Participate in team meetings, contribute insights and updates, and document errors for analysis and improvement, facilitating identification of patterns and areas for enhancement.
• Log all complaints into the complaint management system, capturing every relevant detail for analysis and resolution.
• Follow up with customers to confirm complaints are resolved and satisfactory, and coordinate with external vendors or service providers for complaints involving third-party services or products.
• Compile complaint data, gather additional information as necessary, and collaborate cross-functionally to provide feedback on potential product enhancements, defects, and safety evaluations.
• Aid in documenting service records, applying precise coding and categorizing service records accordingly.
• Utilize basic knowledge of regulations, requirements, and standards to execute post-market surveillance complaint tasks in line with regulatory mandates.

What you'll need

• 5+ years of medtech industry experience.
• Bachelor's degree in any Engineering.
• Post-Market Surveillance Mechanisms; Quality Management Systems (QMS); Quality Specifications; Data Analysis & Interpretation; Regulatory Requirements; Technical Documentation; CAPA Methodologies; Continuous Improvement; Complaint Management; Recordkeeping; Vigilance Reporting; Business Acumen.

Details

• Location: Pune.
• Work mode: office-based teams work in-person at least 3 days per week.