Prasad Settipalli
@prasadsettipalli
I investigate medical device and pharmaceutical quality issues to strengthen compliance, product safety, and audit readiness.
United StatesWhat I'm looking for
At Abbott, I manage post-market complaint investigations for Class II medical devices, evaluating returned products, performing functional testing and failure analysis, and using complaint trends to support CAPA and product improvement.
I've also supported quality and manufacturing operations at Catalent and Medtronic, reviewing batch records, deviations, nonconformances, validation documentation, and controlled records in regulated environments. I work closely with Manufacturing, Engineering, Quality Control, Validation, Regulatory Affairs, and Operations to resolve quality risks and maintain FDA, EMA, cGMP, ISO 13485, ISO 14971, GDP, and QMS compliance.
Experience
Work history, roles, and key accomplishments
Manage post-market quality activities for Class II medical devices, including complaint handling, product investigations, and root cause analysis. Ensure compliance with FDA 21 CFR, ISO 13485, and QMS requirements.
Education
Degrees, certifications, and relevant coursework
University of Maryland Baltimore County
Master of Science, Data Science
Master's degree in Data Science from the University of Maryland Baltimore County.
Availability
Location
United StatesAuthorized to work in
Job categories
Skills
Interested in hiring Prasad?
You can contact Prasad and 90k+ other talented remote workers on Himalayas.
Message PrasadGet matched with your dream remote job
Sign up now and join over 250,000+ remote workers who receive personalized job alerts, curated job matches, and more for free!
