Sign in

Quality Engineer, Medical Devices, CAPA, Continuous Improvement

Warsaw, Indiana, United States
April 16, 2018

Contact this candidate



*** ********** **, ******, ** 46580 +1-716-***-****



Industrial Engineering graduate with a strong analytical and statistics background with experience in Lean Manufacturing, Six Sigma, Continuous Improvement, Quality and Data Analytics.


University at Buffalo, State University of New York Feb 2017

Master of Science in Industrial and Systems Engineering GPA 3.20/4

Siddaganga Institute of Technology, Tumkur, India

Bachelor of Engineering in Industrial Engineering and Management GPA 3.42/4 Jun 2014


Industrial Engineering skills: TPM, OEE, VSM, 5S, SMED, Poka Yoke, SPC, NCR, DMAIC, JIT, CAPA, DOE, FMEA, 8D, GD&T, SCAR, HHE, FDA 21 CFR820, ISO9001, ISO13485

Programming Languages: C, C++, CNC/CAM, R

Tools: Solid Edge, CAED, Solid Works, Arena, CREO Parametric, Minitab, Sixth Sense ERP, Microsoft Office (Excel, Word, Outlook, Power Point, Visio), MySQL, Mapics XA, Oracle JD Edwards


●ASQ Certified Six Sigma Black Belt (Certification number 18431) Oct 2016


Zimmer Biomet Warsaw, IN: Jul 2017 - Present

Quality Engineer:

●Work with the Health Hazard Evaluation (HHE) Team on remediation project for HHE/HHE Determination as a part of Action Implementation stage of a CAPA.

●Work on NCRs, GRNs and existing nonconforming HHEDs. Investigated and documented onto the new HHED/HHE in a timely manner.

●Investigate customer complaints to determine product failure root causes and evaluate risk of failures.

●Investigate related failures, design, and manufacturing history of failed devices.

●Trend and Analyze post market product failure data and provide updates to Division quality leadership.

●Author the technical assessments and other information to be used in Product Hold and Product Field Actios.

●Review CAPA/SCAR reports, DHFs, Product drawings, customer complaints and quality inspection reports and determine whether the nonconformance poses a threat and determine if a field action is necessary.

●Perform and approve Master Validation Plan, IQ, OQ, PQ and TMVs.

Volvo Construction Equipment Bangalore, India: Jun 2016 – Aug 2016

Continuous Improvement Intern: Poka Yoke for kit charging process

●Adopted DMAIC framework in addressing the issue and designed a kit charging board.

●Helped in deskilling the material picking process, achieved JIT and SMED.

●Stores related hand-on calls reduced by 7%.

Continuous Improvement Intern: Android application to facilitate material picking

●Developed an android application to eliminate COPQ.

●Productivity improvement with 6 man days saved and operator efficiency increased by 75%.

Westminster Economic Development Initiative Buffalo, NY: Sep 2015 – Dec 2015

Six Sigma Project Trainee: Process Optimization in critical business areas

●Used forecasting methods and developed a demand prediction model for stabilizing the food cart business.

●Root cause for the problem was found by doing ‘Why-Why analysis’ and ‘Pareto analysis’.

●Proposed auditing methods for efficient tracking of the gift coupon service and carried out 5S for the office space.

●Estimated an annual savings of $18300 by the end of the next fiscal year.

Welform Bangalore, India: Jan 2015 – Jun 2015

Industrial Engineering Intern:

●Performed Methods - Time Measurement and Value Stream analysis.

●Implemented Total Preventive Maintenance and 5S.

●Designed Standard Operating Procedures (SOP) for different processes.

●Assisted in periodic Quality evaluation using gauges and Statistical Process Control tools.

Accutech Enterprises Bangalore, India: Jan 2014 – Apr 2014

Industrial Engineering Intern: Application of Group Technology

●Carried out layout analysis using Rank Order Clustering and Direct Clustering Analysis using the DMAIC framework.

●Developed Cellular Manufacturing Layout and compared cell efficiencies by simulating the material movement.

●Reduced total material movement by 26% and increased the Cell Efficiency by 68%.

●Implemented improvements to the 5S system, developed checklists and check sheets to maintain the same.


Quality Assurance

The Design of experiments to transfer bearings using SPC and Process Capability Analysis, SUNY, Buffalo, NY

●Designed an experiment to determine the best electromagnetic settings to maximize the number of ball bearings transferred from a bulk container to final packaging.

●Collected data to perform measurement systems analysis, Fractional Factorial design for statistical analysis.

●Utilized quality assurance tools such as response surface modeling, statistical process control, Gauge R&R and process capability analysis to achieve repeatable response variables.

Design and Experimental Analysis of foam height from Root Beer, SUNY, Buffalo, NY

●Analyzed factors involved for foam created while the beer dispensed in a glass.

●Used regression analysis, factorial design, surface response methodologies (RSM) to filter data, select parameters and carried out statistical analysis to achieve the desired amount of foam height in Root Beer using MINITAB.

Lean Manufacturing

Value Stream Mapping, SUNY, Buffalo, NY

●Analyzed the Current State Map and proposed the Future State Map for Acme’s stamping process.

●Using lean techniques, lead-time was reduced to 4.5 days from 23.6 days and processing time was reduced to 169 seconds from 188 seconds.


●National Service Scheme Coordinator for two academic years. Aug 2012 – Apr 2014

Contact this candidate