Gautami Patel

About Gautami Patel

Highly motivated, detail oriented individual with strong problem solving, organizational, interpersonal and leadership skills interested in gaining a wider range of experience in the medical device or pharmaceutical industry.Specialties: MATLAB, Minitab, MS Office, MS Project, Project Management, Technical Writing, Validation deliverables - Validation Master Plan (VMP), Validation Summary Report,Corrective and Preventive Action (CAPA), Root Cause Analysis, FMEA, Quality Manual,Quality Management System, Standard Operating Procedures(SOPs), IQ/OQ/PQ, Risk Analysis, Risk Assessment(RA),cGMP, GLP and GDP guidelines, 21 CFR part 11, part 210,part 211, part 820 and ICH guidelines, Tech Transfer, New Product Introduction, Risk Management (ISO 14971), Design Control, pFMEA, Six Sigma Green Belt, ISO 13485: 2016 certified, Biocompatibility ISO 10•••••18, Sterilization Validation, ISO 11607 Packaging Validation, UDI labeling, Gap Analysis, Audits, Cleaning Validation, Cleanroom Qualification and Validation

Experience

1. Principal Quality Engineer

   Amplifi Vascular, Inc

   May 2023 — Present

Education

• New Jersey Institute of Technology

  Master of Science, Pharmaceutical Engineering

• New Jersey Institute of Technology

  Bachelor of Science, Biomedical Engineering

Skills

• Six Sigma
• Data Collection
• Technical Writing
• Quality System
• Biomaterials
• Microsoft Project
• Matlab
• Medical Devices
• Capa
• Biomedical Engineering
• Biotechnology
• Quality Assurance
• Pharmaceutical Engineering
• 21 Cfr Part 11
• Biomechanics
• Validation
• U.s. Food and Drug Administration (Fda)
• Tissue Engineering
• R&D
• Root Cause Analysis
• Cad
• Glp
• Pharmaceutical Industry
• Sop
• Fda
• Microsoft Office
• Gmp
• Ms Project