Quality Assurance Project

GAURANG MAHALE

*** * **** ****** ● Apartment #** ● Los Angeles, CA 90007 ● 213-***-**** ● *************@*****.***

LinkedIn Profile: http://lnkd.in/bW6Hh6p

E DUCATION:

• GPA: 3.73

Master of Science in Biomedical engineering

Expected May 2014

University of Southern California, Los Angeles, CA.

• Aggregate:77.77% J une

Bachelor of Engineering in Biomedical Engineering

2 012

University of Mumbai, India

RELEVANT COURSEWORK:

Quality Systems and Standards, Regulation of Medical Devices and Diagnostics, Engineering Project Management, Signal and

Systems Analysis, Advanced Topics in Biomedical Systems, Advanced Studies of the Nervous System

WORK EXPERIENCE:

MediVision, Inc. - Regulatory Affairs and Quality Assurance Intern S ummer 2013-Present

• Quality Assurance:

A ssisted the company in preparing for customer audits, Conducted internal audits of the quality system of the

c ompany, Assessed compliance with ISO 13485 and 21 CFR 820 standards, Actively participated in the audit

m eetings and follow up activities, Reviewed the quality manual, quality procedures, SOPs and other quality

d ocuments of the company, Updated the internal audit checklist to incorporate both ISO 13485 and 21 CFR 820

s tandards, Reviewed the Risk Management quality documents and checked compliance with ISO 14971

s tandard, Drafted design documents for preparing the design history file (DHF) of products, Prepared the

d evice master record (DMR) files for products, Assisted the quality control clerk in performing receiving

i nspection of incoming product parts

• Regulatory Affairs:

C ollected preliminary data for 510k submission, Analyzed predicate device data, Actively participated in

Management Review meetings and made suggestions, Researched regulations for CE marking and wrote a

r eport specific to the product, Reviewed applicable technical standards for the product, Reviewed labeling of

products, Drafted product specification and instructions for use statements, Organized and maintained

r egulatory documentation like SOPs, NCMRs, CAPA reports, engineering drawings and forms

USC PROJECT EXPERIENCE:

Audit Project S pring 2013

Acted as a quality auditor for a small US company, conducted a mock internal audit in accordance with 21 CFR

8 20 and ISO 13485 and prepared an internal audit checklist

510k Document Preparation F all 2012

Drafted a traditional 510k document for a dental impression material

Regulatory Strategy F all 2012

Developed a regulatory strategy for a non-compliant product by obtaining PMA and IDE approval

Quality Documents Preparation S pring 2013

S imulated the manufacturing process of popcorn as a medical device compliant to cGMP’s and composed the

P opcorn Manufacturing SOP, Finished Popcorn SPEC and Controlled material/tool SPEC

Formula One Car Project F all 2013

Built a Work Breakdown Structure for a Formula One Car using Project, created a project charter, scope statement

a nd project plan

Study of Typical Action Potential F all 2012

Simulated a typical neuronal action potential using MATLAB, incorporated the effect of an additional channel and

wrote an IEEE format report on the same

S tudy of pattern association in cerebellum F all 2012

Simulated a conceptual model of the cerebellum based on the associative net theory using MATLAB and wrote an

I EEE format report on it

SOFT SKILLS:

Software: MS Office, Project, MATLAB

GAURANG MAHALE

742 W 27th Street ● Apartment #34 ● Los Angeles, CA 90007 ● 213-***-**** ● *************@*****.***

LinkedIn Profile: http://lnkd.in/bW6Hh6p

Operating Systems: Windows

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