Rumiya Bhattacharjee

MEDICAL DEVICE | COMPLAIN INVESTIGATOR | SOFTWARE QUALITY ANALYST| VIGILANCE SPECIALIST

Role
Vigilance Specialist at Cyient
Location
Bengaluru, KA, IN
LinkedIn followers
500 followers
Public Administration & SafetyView LinkedIn profile

About Rumiya Bhattacharjee

I have more than 5 years experience in Biomedical field.Have worked in Superspeciality…

Experience

  1. Vigilance Specialist

    Cyient

    Feb 2025 — Present · Hyderabad, IN

    Complaint Assessment: Reviewing and assessing complaints received from customers, healthcare professionals, or internal sources regarding the company\'s medical devices. Documentation: Accurately documenting complaint details, including the nature of the issue, patient impact, and any relevant product information. Investigation: Conducting thorough investigations into complaints, which may involve coordinating with cross-functional teams, product engineers, and quality assurance personnel.4. Regulatory Compliance: Ensuring that all complaint handling procedures adhere to regulatory requirements, such as FDA regulations for medical devices. Root Cause Analysis: Identifying the root causes of device-related issues and working on corrective and preventive actions to address them. Customer Communication: Managing communication with customers and healthcare providers to provide updates on the status of complaint investigations and resolution. Trend Analysis: Analysing complaint data to identify trends and recurring issues, and making recommendations for product improvements or quality enhancements. Reporting: Preparing and submitting comprehensive reports to regulatory authorities, as required, and maintaining accurate records of all complaint-related activities. Continuous Improvement: Contributing to the development and improvement of the company\'s complaint handling processes and quality management systems. Quality Assurance: Collaborating with the quality assurance and regulatory affairs teams to ensure that medical devices meet safety and quality standards. CAPA Management: Have experience in CAPA management and documentation.

Education

  • Netaji Subhash Engineering College

    Bachelor of Technology (B.Tech.)

    2013 — 2017

  • Bidhan nagar govt.high school

    Higher Secondary

  • Baghbazar Multipurpose Girls school

    High School

    2010

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Rumiya Bhattacharjee — Vigilance Specialist at Cyient in Bengaluru, KA, IN | Unifers