Sneha K.

About Sneha K.

With over a decade in the Life Sciences & Medical Devices Industry, my role at INDIUS Medical Solutions emphasizes regulatory compliance and the implementation of Quality Management Systems in line with global standards. At the core of my expertise lies a proven track record in managing Quality Assurance and Regulatory Affairs, with a sharp focus on maintaining systems compliant with CDSCO India, ISO 13485, ISO 14971, and FDA 21 CFR Part 820. Driven by a mission to uphold the highest quality standards, my responsibilities extend to conducting internal audits, ensuring readiness for external inspections, and spearheading the integration of new regulatory requirements. Our team has successfully developed standardized processes for CAPA management, deviation, and change control, contributing to the organization\'s reputation for excellence in the ever-evolving medical device sector.

Experience

1. Sr Quality Assurance and Regulatory Affairs Specialist

   INDIUS Medical Technologies

   Feb 2020 — Present · Pune, IN

   Implementing and maintaining Quality Management System (QMS) that complies with CDSCO India, ISO 13485, ISO 14971 and FDA 21 CFR Part 820.# Handle External Audit for CDSCO, ISO 13485 and US FDA inspections andcertifications.# Assists in the development and maintenance of company procedures fordesign control, change managements, risk management, processvalidation, and related areas of the quality management system.# Conduct internal audit.# Implement new CDSCO 2017 MDR requirements.# Assist in any US FDA and CDSCO related product approvals.# Develop and implement quality control and inspection procedures forreceipt and control of incoming materials, in-process materials and finalproduct acceptance activities.# Analyze failure, corrective and preventive action to respond tointernal/external customer complaints.# Reviews and approval of Document Change Records (DCRs) within thedocumentation system.# Represents design quality functions for review and approval ofdesignated design outputs.# Responsible for working closely with PMS (Post Market Surveillance) to evaluate the customer complaints and also responsible for providing technical/engineering support regarding customer complaints and product returns. Investigation involves product evaluation, DHR to determine root cause of potential product failure.

Education

• Shivaji College Udgir

  HSC

  2004 — 2005

• SRTM University Nanded

  Bachelor of Science (B.Sc.)

  2005 — 2008

• Dr. B.A.M. University Aurangabad

  M.sc

  2008 — 2011