Engineering Quality

MOURYA BOMMIREDDY VENKATA SUNDARA

ac0wmc@r.postjobfree.com 609-***-****

www.linkedin.com/in/mourya-bv-sundara-095393124

BSI certified Lead auditor – ISO 13485

EDUCATION

NEW JERSEY INSTITUTE OF TECHNOLOGY, NEWARK, NJ May, 2016 Candidate for Master of Science Degree in Biomedical Engineering

BIRLA INSTITUTE OF TECHNOLOGY AND SCIENCE, PILANI, INDIA June, 2014 Candidate for Master of Science Degree(2 years) in Biological sciences and Bachelor of engineering (4 years)in Chemical Engineering

OBJECTIVE STATEMENT

BSI certified iso9001:13485 lead auditor with 3 years of quality engineering real-time experience In manufacturing(metal fabrication and assembly), R&D and design Industry.

In pursuit of a challenging role in quality engineering and management in manufacturing industry

WORK EXPERIENCE

QUALITY INSPECTOR / ENGINEER (SEPT 2016 TO PRESENT)

•Performed inspection in all departments including receiving inspection, shipping, assembly, in – process inspection . Knowledge of inspection techniques, measurement devices, calibration of devices and dimentional tolerancing

•In- depth knowledge of the concepts of engineering change control, statistical process control techniques, and

IQ validation protocols

•Have knowledge of and operated the comparator for measurement purposes

•Performed Fabri-vision machine programming, validation of new and existing equipment .

•performed risk assessment on process and parts .

•Adept at using tools like root-cause analysis, 5 Y method, fish bone diagram analysis etc..

•Participate in Engineering Change meetings and make sure quality of part being designed will be meet ISO 13485 standards

•Familiar with FDA Quality System Requirements/ISO 13485, quality auditing, and engineering drafting. Performed internal audits for the organization . ISO 13485 Lead auditor certified Bsi.

•Sound knowledge of Solid Works, ISO (ISO: 13485) regulations, Gage R&R, and CREO3.0; SOLID WORKS .

Designed CAD design projects with more than 200 hours of work put in

•Receive and process return material authorization for customer returned parts

ACHIEVEMENTS AT MEDIN CORPORATION & WHY I WILL BE A GREAT HIRE

•Worked In an inter-departmental capacity – working with the quality supervisor, manufacturing supervisor/manager, design engineers

•Extremely adaptable and have successfully worked with professionals from all over the world.

•Experience of leading teams to success and project deadlines. Goal oriented and motivated professional.

•Interacted with customers and successfully met the set targets.

•Highly effective at communicating the information and execution of process maps

•Resolve ongoing, spontaneously occurring issues during production with a calm head thus maximizing the possible outcome.

PROJECT MANAGEMENT AND TEAM LEAD EXPERIENCE

Handling customer complaints, new product design reviews, supplier incoming inspectors Quality analyst – UNITED SPIRITS, INDIA

•Food safety standards audit and HACCP audit

•Handling corrective and preventive actions after root cause analysis

•Analyzing assembly line defects

•Root cause analysis and suggesting improvements

•Documentation to meet ISO9001 and food safety standards

•Training of operators

Research Analyst Intern for CENTRAL LEATHER RESEARCH INSTITUTE, Chennai, India June 2013 – June 2014 Successfully delivered a predictive algorithm to predict the growth of the fungus Aspergillus tamarii

•Achieved 90% Accurate prediction of Fungal Growth

•Performed Regression analysis and Statistical Process control techniques

•Developed a comprehensive report on the various activities performed at the Rourkela steel plant

Quality Engineering Intern, Rourkela Steel Plant, Orissa, India June 2012- September 2012

•Implemented Quality control Techniques to minimize loss of Raw material in the cold rolling mills at Rourkela Steel Plant

•Studied the process of Cold rolling and worked on Implementing Changes aimed at efficiency and safety

•Improved safety measures by designing new safety protocol Procedures

TECHNICAL PROJECTS

HIP DISLOCATION ANALYSIS - IMPROVING RANGE OF MOTION OF Stryker Corporation’s Total Hip Implant Researched upon activities of daily living leading to hip dislocation post total hip surgery.

•Developed a Protocol for recreating the identified ACTIVITIES OF DAILY LIVING in the GAIT LAB at NJIT, Newark

•Recorded the Joint angles, Flexion angles, Abduction and Adduction angles and internal rotation angles corresponding to the performed activities, ensuring FDA compliance Consequently improved Stryker Hip Implant’s RANGE OF MOTION

STRESS – STRAIN ANALYSIS OF HUMAN BRAIN UNDER FRONTAL IMPACT

•Formed 3-D image of the brain using 2-D FMRI images using the Mimics software Simulated a frontal impact on the head using ANSYS Simulation software.

•Formed a time dependent model of the human head under frontal impact

CAD DESIGN OF TOTAL KNEE IMPLANT & HUMAN EXOSKELETON FOR KNEE INJURIES USING CREO 3.0 Researched upon the various human exoskeletons in the market.

•Developed a novel design of a Total knee Implant using CREO 3.0

•Designed own novel version of human exoskeleton for assisting patients with knee injuries

•Over 200 hours of work put into developing each CAD model

•ISO 13485 &FDA/cGMP Regulation followed during Design inputs and design process

LEADERSHIP SKILLS

PRESIDENT –Graduate Biomedical Engineering Society, NJIT January 2016 – May 2016

DEPARTMENT REPRESENTATIVE –Biomedical Engineering Department, NJIT September 2015 – May 2016

•Built a Team of students to work for the cause of making GBMES an active club at NJIT

•Initiated GBMES INDUSTRY TALKS to bring in more industry involvement at NJIT – Invited Werum IT solutions

•Improved NJIT’s Visibility and Ranking – was part of the student association which hosted cultural and Technical events

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