Kritika Lakhotia
Senior Quality Engineer @Boston Scientific
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WORK HISTORY
Senior Quality Engineer @Boston Scientific
CA
Subject Matter Expert for integrating quality elements & processes of acquired entities to Boston Scientific processes/systems. Recent experience involved working and leading Production and Process Controls integration for transeptal access sheaths and dilator products. Specific activities included- TMV quality assurance - Process Risk Analysis and Master Validation Plans - In-process monitoring deliverables - PV & V strategies - Workstation Vulnerability Assessments
EDUCATION
Vellore Institute of Technology
Bachelor of Technology (B.Tech.)
University at Buffalo
Master of Science (MS)
SKILLS
ABOUT KRITIKA LAKHOTIA
I’m a Certified Lean Six Sigma Green Belt Quality Engineer in the medical device industry with demonstrated success in seamlessly incorporating quality requirements within products and processes that improve patient lives globally. I thrive in bringing technically and economically sound solutions to the table with a methodical approach. I approach my work with care and keen willingness to keep learning!Quality Background and Skills: ISO 13485, ISO 14971, 21 CFR 820, Health Canada, EU MDD, EU MDR, QMS integrations, pFMEAs, Test Method Validations, Process Monitoring, Root Cause Analyses, Complaint Handling/Reporting, Audit Management, Training.Please contact at k••••••••@gmail.com for any interesting opportunities. I’m always willing to be open to new roles and see what’s out there!
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