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Medical Quality

Los Angeles, California, United States
February 25, 2018

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Prerana Gurubasavaraj / 213-***-****

*** **** **** ******, **, CA 90007


University of Southern California, Viterbi School of Engineering Los Angeles, CA Master of Science, Biomedical Engineering (Medical Device & Diagnostic Engineering) May 2018 Related Course Work

BME 502 Advanced Studies of the Nervous System

BME 513 Signal and Systems Analysis

MPTX 513 Regulation of Medical Devices & Diagnostics

MPTX 517 Structure and Management of Clinical Trails

BME 650 Biomedical Measurement and Instrumentation

BME 551 Introduction to bio-MEMS and Nanotechnology

ISE 527 Quality Management for Engineers

ISE 508 Health Care Operations Improvement

RNSIT, Visvesvaraya Technological University Bangalore, India Bachelor of Engineering in Electronics and Communication May 2014 PROFESSIONAL EXPERIENCE

Applied Medical Resources Corporation Rancho Santa Margarita, CA Regulatory/Quality R&D Intern 2017

Maintained regulatory documentation database and logs in a format compliant with ISO standards and FDA regulations.

Drafted regulatory memos for design and labeling updates related to currently marketed devices in the United States, European Union, Canada, Australia, New Zealand, South Korea, and Mexico.

Compiled Gap/Impact analysis for devices or systems affected by the revision of standards and assessed potential actions required to maintain compliance.

Played a key role in the GUDID/UDI project as a Labeler Data Entry (LDE) user and provided support for Biocompatibility and WAND database audits.

Helped manage and implement changes to the enterprise resource management system to allow for better documentation.

IBM India Pvt Ltd Bangalore, India

Associate System engineer – Test Automation Specialist 2014 – 2015

Scripted test cases using HP ALM tool. Created test data and used test data for execution with HP UFT.

Performed Cycle 0 Testing for Applications during Production Changes.

Executed Retail Management Systems on iOS platform for Sprint.

Certified in UFT and RFT Automation Tool by IBM. SKILLS

Microsoft Office utilities, SAP-PLM, LTSpice, MATLAB, HP ALM, Citrix Remote Machine, RFT and HP UFT.

Regulatory Compliance, GCP, GMP, 510k, 21 CFR, FMEA, RCA, QMS, ISO 13485, Process Improvement, Lean, Six Sigma, Quality Management, Quality Assurance, Project Management. ACADEMIC PROJECTS

Quality Improvement Project at the Veteran Affairs (VA) Hospital 2017 Identified root causes for guidewire retention in a CVC process through patent and literature reviews and critically assessed engineering solutions to minimize or remove human error under the guidance of Dr. Miriam Schwartz and Dr. Douglas Paull.

Clinical Trial Protocol Review by the Site working group 2017 Performed the role of a Principal Investigator for a Placebo-Controlled, Triple-Blind, Randomized Crossover Pilot Study of the Safety and Efficacy of Four Different Potencies of Smoked Marijuana in 76 Veterans with Chronic, Treatment-Resistant Posttraumatic Stress Disorder.

Quality system project 2017

Developed a quality system by conducting process validation, quality control, PFMEA, DFMEA, and QFD. Built a prototype for a business and created a quality manual that is compliant to the ISO9001:2008 standard.

Paper on Micropump For Drug Delivery Driven by Ultrasound 2017 Presented a paper on Micropump for drug delivery driven by ultrasound to treat Optic Neuritis.

Mock 510(k) submission for Class II medical device 2016 Presented a 510(k) document to the Regulatory Sciences Department of University of Southern California for the medical device ‘Physioline Needle Electrode’, which is a single patient disposable needle electrode used for Electromyography

(EMG) guided injections.


Graduate Student Worker, USC Academic Senate, and Graduate Admissions Office.

Dance Instructor, Studio Caadencia.

Facilitator, for the volunteer initiative Smileys, Bangalore.

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