Complaint Handling Engineer

Business Overview:

Tata Elxsi is among the world’s leading providers of design and technology services across industries, including Automotive, Broadcast, Communications, and Healthcare. Tata Elxsi is helping customers reimagine their products and services through design thinking and the application of digital technologies such as IoT (Internet of Things), Cloud, Mobility, Virtual Reality, and Artificial Intelligence

Qualification –

• Bachelor or Master of Science, preferably: Biomedical, Mechanical Engineering, Biotechnology, Biochemistry, Pharmacy or similar

Experience-

• At least 3 to 5 years of experience including experience in leading teams and managing daily operations, preferably in complaint management

• Experience in complaint database such as SAP, Trackwise, Salesforce etc. • Holds knowledge of monitoring and tracking of report submission in accordance with related standards, regulatory timelines

• Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint)

Key Responsibilities-

• Medical devices Complaint handling- Complaint processing including Complaint Intake, Product details, Triage, Decision tree, Complaint closure

• Vigilance reporting

• IMDRF and FDA coding's

• Complaint investigation

• Due diligence

• Mailbox monitoring and handling

Responsibilities may include the following and other duties may be assigned

• Evaluates incoming complaint information and maintains the record in the electronic database

• Performs follow up activities to obtain additional information. Use and maintain database(s), provide analysis and trending data all on complaints.

• Determines Reportability of complaints to regulatory bodies.

• Identify and document appropriate complaint categories to assure trend accuracy within the complaint database.

• Writes investigation summaries based on technical product analysis information provided

• Prepare and submit the MedWatch-3500A Report, MIR Report, Initial, Follow-up, and Final Reports to the respective competent authorities in compliance with regulations, guidelines, and the required timeframe.

• To check the customer feedback and initiate follow-up for additional information

• Performed coding activities on the assigned projects with timelines and efficiency.

• Assure the accuracy, integrity, completeness, and consistency of all product complaint investigations of MDR and other Vigilance reports.

• Performed QC on all types of records and other related duties as directed by management

• Ensures record documentation is maintained in a constant state of audit readiness per internal policies.

• Liaison with groups who perform additional investigation and who prepare written record of investigation.

• Interact with Technical Service, Manufacturing, R&D, and Quality Assurance, as needed, during the course of complaint processing.

• Provide basic technical expertise and assistance in handling complaints to comply with current FDA and International reporting