Sneha Nair

About Sneha Nair

I hold a Master\'s degree in Biomedical Engineering with a specialized focus on Engineering Management, offering a comprehensive understanding of both technical intricacies and managerial perspectives. With over five years of dedicated experience in medical device compliance, quality assurance, and regulatory affairs, my commitment to contributing to the healthcare sector remains unwavering. My expertise spans a broad spectrum of regulatory frameworks, including ISO 13485, 21 CFR 820, CAP/CLIA, GCP and EU IVDR.Utilizing Lean Quality Tools such as FMEA, Pareto Charts, Fishbone Diagrams, Control Charts, and Histograms, I have successfully navigated critical aspects of quality management. My familiarity with FDA regulations and EU-MDR requirements enables me to effectively execute tasks related to Corrective and Preventive Actions (CAPA), risk management, validations, design controls, supplier management, root cause analysis, change control and packaging and labeling compliance.Moreover, I have hands-on experience with various ISO standards, including ISO 14971 and ISO 9001, ISO 13485 and a profound understanding of QMS essentials such as SOPs, cGCP, GMP, 510(k), and IDE processes. My commitment to continuous improvement and adherence to best practices in regulatory compliance and quality assurance make me well-equipped to excel in the dynamic landscape of medical technologies. I am actively seeking opportunities to leverage my skills and expertise towards advancing healthcare innovation.

Experience

1. Senior Quality Assurance Specialist, Gcp

   Tempus AI

   Aug 2024 — Present

Education

• Thadomal Shahani Engineering College

  Bachelor's degree, Biomedical/Medical Engineering

• Syracuse University

  Master's degree, Bioengineering and Biomedical Engineering