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Quality Engineer Resume Example

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QUALITY ENGINEER
Summary
ASQ CERTIFIED QUALITY ENGINEER (CQE) and Lean Six Sigma Green Belt Professional with 3+ years of experience in manufacturing and medical device industries, working in a regulated environment performing Root cause analysis, QECR's, Gage R&R and Process & Packaging Validation and Project management *Good experience working on NCR, QECR, GRN and Quality holds *Experience with engineering design, document control, design control and process control in both engineering and manufacturing departments *Good understanding of ISO 9000, ISO 13485, FDA 21 CFR 820 and FDA Quality systems *Working knowledge on writing documents like Standard Operating Procedures(SOP's), work instructions, technical files *Experience performing validations (IQ, OQ, PQ), CNC Machining and MRB *Familiar with drafting standards, blue print and technical drawing reading, Design of Experiments (DOE), GMP, GD&T, QSR and Lean Manufacturing Techniques, creating and maintaining DHF, DMR and NCR *AutoCAD Certified associate, proficient in CATIA and Creo, Computer Aided Drafting (CAD) *Strong experience working on Statistical Process Control (SPC), 5S, kaizen, Gage R&R Studies, Test Method validation and Process Monitoring *Strong skills with Risk Assessment, Corrective Action and Preventive Action (CAPA) investigation, Failure Mode Effect Analysis (FMEA)
Skills
  • MS Word, Excel, Power Point, Visio, Project, Access and Outlook
  • Design/Analysis Software : AutoCAD, Creo, CATIA V5, MAT LAB, Minitab
  • Methodologies : 5S, Root cause analysis, Kanban, Kaizen, DMAIC, DFM, DFA
  • Problem solving tools : PDCA, 5-why analysis, Fishbone Diagram, FMEA
  • Production tools : DFMEA and PFMEA, Six Sigma concepts, Lean tools, ENOVIA
Experience
September 2016 to CurrentQuality Engineer
Warsaw, IN
  • Working with a team to develop an implementation strategy to retrospectively create and maintain Design History Files(DHF) and Device Master Record (DMR) as per FDA 21 CFR 820 for medical device products.
  • Creating flowcharts, explanatory documents and project plans and organize and execute gap analysis for DHF and participating in MRB meetings.
  • Issue Evaluation (IE), Evaluation of Non-Conformance Product (NCR) and Engineering Change Notices (QECR) and Gage Rejection Notice (GRN), supporting CAPA activities.
  • Writing documents like Standard Operating Procedures(SOPs), Performing validations like Installation Qualification(IQ), Operational Qualification(OQ), Performance Qualification(PQ).
  • Identifying critical personnel, gauges, procedures, and materials needed for the completion of new products, Identify and reducing quality risks.
  • Participating actively in internal process audits and FDA regulatory audits.
  • Experience calculating the capabilities and determining the sampling levels for inspection.
  • Working on in-process product and process quality problems, Experience with CNC's, lathes, milling, grinding, finishing and cleaning equipment and working on product non-conformances.
  • Developing project plans and schedules for work activities, performing and evaluating process and performance capability studies (Cp, Cpk, Ppk) Performing First Article Inspection (FAI/FAL).
  • Training new and existing operators and to the existing and new procedures, introducing new operating procedures, work instructions, GMP and GDP.
  • Performing Gage R&R study, writing report and determine if the gage can be used for measurement or any improvements are to be made.
  • Ensuring that suppliers have necessary information and facilities to deliver quality products.
  • Experience working with drafting standards, blue print reading and preparing Engineering Change Notices (ECN).
  • Statistical process control of sterile packaging process, test and documentation of results.
  • Verifying manufacturing process forms and deviation reports of manufacturing and packaging process.
  • Experience with root cause and risk assessment tools (DMAIC, fishbone) via investigative work.
University of MississippiAugust 2014 to May 2016Graduate Research Assistant
Oxford, MS
  • Constant Velocity Combustion Scramjet Analysis.
  • Derived the equations for the performance parameters of the scramjet engine based on Brayton cycle.
  • Performance of a constant velocity combustion scramjet engine is determined parametrically by analyzing the engine parameters.
  • Supervised students in lab, resolved the issues involved with equipment(s) by using effective troubleshooting techniques.
  • Sample preparation following ASTM standards, co-ordination and performing experiments.
  • Assisted undergraduate students in understanding the critical concepts of heat transfer, design and other engineering disciplines.
  • Maintaining the IT labs, Troubleshooting, Installing OS (Windows) and software.
  • Helped the faculty in organizing classes, tests and in grading the home works of students.
Sri Madhavi EngineeringJuly 2012 to July 2014Manufacturing Quality Engineer
AP
  • Manufactured components with metals and plastics using different manufacturing processes including machining, casting, fabrication and injection molding.
  • Designed layout of equipment, workspace, and Work-In-Progress (WIP) storage for production.
  • Developed and tested prototype of the nozzles and pipe joints and created bill of materials.
  • Developed layouts, part routings, production plan and reduced production time based on queue lengths.
  • Successfully implemented batch production and reduced the capital, inventory, machinery by about 30%.
  • Increased productivity and decreased waste from manufacturing process by implementing kaizen.
  • Reviewed and performed GD&T, prepared go and no-go gages for quality inspection PUBLICATIONS:.
  • Roux J.
  • A., L.
  • S.
  • Tiruveedula., "Constant Velocity Combustion Parametric Ideal Scramjet Cycle Analysis", Journal of Thermophysics and Heat Transfer.
  • 2016 (http://dx.doi.org/10.2514/1.T4792 ).
  • Roux J.
  • A., L.
  • S.
  • Tiruveedula., "Constant Velocity Combustion Scramjet Cycle Analysis for Non-Ideal Mass Flow Rate", Thermal Science and Engineering Progress.
  • 2017 (DOI: 10.1016/j.tsep.2017.03.003).
Education and Training
University of MississippiMaster of Science: Mechanical EngineeringMechanical Engineering
May 2016MS3.46/4.0
JNTUKBachelor of Technology: Mechanical EngineeringMechanical Engineering 3.6/4.0
Skills
AutoCAD, blue print reading, CATIA, CNC, documentation, drafting, cleaning equipment, experiments, forms, GMP, http, Inspection, IE, inventory, IQ, lathes, layout, machinery, machining, manufacturing process, manufacturing processes, materials, meetings, Access, Excel, Office, Outlook, Power Point, Windows, MS Word, works, Minitab, OS, OQ, organizing, packaging, personnel, PQ, Problem solving, Progress, project plans, PUBLICATIONS, quality, risk assessment, Sample preparation, Six Sigma, Statistical process control, strategy, Troubleshooting, Visio
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Resume Overview

Companies Worked For:

  • University of Mississippi
  • Sri Madhavi Engineering

School Attended

  • University of Mississippi
  • JNTUK

Job Titles Held:

  • Quality Engineer
  • Graduate Research Assistant
  • Manufacturing Quality Engineer

Degrees

  • Master of Science : Mechanical Engineering
    MS
    Bachelor of Technology : Mechanical Engineering

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