Complaint Handling and Vigilance reporting

Job Title

Job Description

Job title:

Complaint Handling and Vigilance reporting

Your role:

• Works under direct supervision and established processes and operational policies, reviews and documents complaints precisely and accurately, ensuring comprehensive capture of relevant information and adherence to regulatory and organizational requirements.
• Ensures detailed records of complaints are maintained, including investigation findings and resolution actions taken, to support post-market surveillance activities and facilitate continuous improvement initiatives aimed at enhancing product quality and customer satisfaction.
• Reviews and assesses complaint intake records from various channels for alignment with complaint definitions and regulatory requirements and conducts duplicate checks to eliminate redundant records and ensure data accuracy and integrity in post-market surveillance activities.
• Conducts moderate Good Faith Efforts (GFE) when necessary to collect additional data, supporting the evaluation and escalation of the record. Collaborates with relevant stakeholders to ensure comprehensive data gathering, adhering to regulatory requirements and internal protocols.
• Ensures application of suitable coding, reviews the input into the complaints process, enhances data organization and analysis, applies reported problem coding to record the customer’s experience, and enables swift resolution and valuable insights for improving procedures and addressing recurring issues.
• Identifies routine mid complexity issues, determines if escalation to a Level 2 or Level 3 Investigator is required and escalates complaint records to a complaint operations specialist or manager.
• Follows internal follow-up measures to procure further essential information necessary for reinforcing the investigation process, ensuring thoroughness and accuracy in analysis and decision-making.
• Compiles records for various topics, presents them at the daily management review meeting, and ensures a comprehensive overview of relevant information for discussion and decision-making.
• Prepares comprehensive investigation reports that include findings, conclusions, and actions taken, ensures accuracy and currency in maintaining complaint files and records to facilitate effective communication of investigation outcomes and support continuous improvement efforts.
Develops stable working relationships internally, exchanges standard information with colleagues, immediate supervisor, project leaders, and other professionals in the team/group.

You're the right fit if: (4 x bullets max)
1. Experience- 2-4years of experience in complaints Handling and Vigilance
2. Skills -

• Post-Market Surveillance Mechanisms
• Quality Management Systems (QMS)
• Quality Specifications
• Data Analysis & Interpretation
• Regulatory Requirements
• Technical Documentation
• Complaint Management
• Recordkeeping
• Business Acumen

3. Education- BE in any engineering
4. Anything else: Good Communication skill, ready to learn