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Customer Service Quality Engineer

Location:
San Antonio, TX
Posted:
February 04, 2018

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Resume:

SRAVANI ac4b07@r.postjobfree.com

+1-361-***-****

PROFESSIONAL SUMMARY

Experienced Quality Engineer in highly regulated environment centered on compliance and delivery of high quality risk assessment, design, implementation, validation, and maintenance solutions. Experience in Verification and Validation, Risk Management and Quality Engineering in the medical device industry. Strong working knowledge on the FDA regulations, 21 CFR Part 820, Part 11, ISO 14971, 13485 and 15223. Hands on experience in Design controls and DHFs, DFMEA, PFMEA and FTA Analysis. Experience with Corrective Action and Preventive Action (CAPA) and root cause investigations including packaging problems. Experienced in Six Sigma and Design for Six Sigma (DFSS) working on class I, II, III medical devices. Extensive knowledge in Statistical Principles and Applications, Failure Mode Effect Analysis (Process and Design). Also holding Internship experience in HSL(Hindustan Shipyard Limited) with excellent communication skills honed through work experience as a Customer Service Associate. Significant academic achievement including a 7.87GPA in bachelors and 3.41 in masters .

TECHNICAL SKILLS:

Design History Files (DHF) Remediation Control Plans ISO 13485, ISO 14971 QSR 21 CFR Part 820 ISO 13485, ISO 14971 Test Method Validation (TMV) Gage Reproducibility & Repeatability Studies (Gage R&R) Fault Tree Analysis

5-Why Analysis Control Process Parameters (CPP) Statistical Process Controls(SPC) Minitab Geometric Dimensioning & Tolerance (GD&T) Six-Sigma, Lean & Kaizen Standard Operating Procedures (SOPs) Design of Experiments (DOE) GxP (GDP, GLP, GMP) DFMEA, PFMEA, FMEA Authoring & Executing Validation Protocols (IQ, OQ, PQ) Inspection Method Validation(IMV) Implementing GxP (GMP, GDP, GLP) CAPA Administration Root Cause Analysis (RCA) Blueprints Closing Nonconformance Reports (NCR) & Nonconformance Material Reports (NCMR) Supplier Audits, Supplier Scorecards & Supplier Metrics Solid works AutoCAD C language HTML Java Ansys EDUCATION

Texas A&M University – Kingsville GPA : 3.41

Masters of Engineering- Mechanical Engineering January 2016- August 2017 Andhra University College Of Engineering For Women September 2010-May 2014 Bachelor Of Engineering – Mechanical Engineering GPA : 7.81/10 CERTIFICATIONS:

"Six Sigma White Belt Certification " - from Management and Strategy Institute.

" Project Management Essentials Certification" - from Management and Strategy Institute.

"SolidWorks Certification" - from Management and Strategy Institue.

" AutoCad " - from GIT Institute of Advanced Technologies. EXPERIENCE

Texas A &M University Kingsville (February 2017 – May 2017) Kingsville, Texas Graduate Assistant in mechanical engineering department under Dr. Yousri Elkassabgi at Texas A&M University- Kingsville.

Amazon Development Centre Hyderabad, India

Customer Service Associate - September 2015 –December 2015

• Received Employee of the Month for excellent customer service

• Led the team in the absence of the team leader

• Acquired strong knowledge of company strategies to attract customers

• Assisting customers with order related issues.

• Assisting users with website.

• Communicate with customers via phone, email and chat, specifically about Amazon Prime related issues

• Utilize a variety of software tools to navigate customer accounts, research and review policies and communicate effective solutions

Astra Medicals Secunderbad, India

Quality Engineer July 2014 – June 2015

• Drafted Engineering Change Orders, process flows, Product Development History documents, IQ,OP,PQ protocols and reports.

• Generated, managed, executed and reviewed IQs, OQs, PQs for Process Validation, Cleaning Validation, equipment qualification and developed final summary reports detailing all the deviations observed and investigations performed to close the deviations per top level procedures.

• Responsible for maintaining Quality System Regulations (Part 820) and Regulatory Standards (ISO 13485/14971).

• Comprehensive understanding of Design History File (DHF) and associated remediation activities

• Corrective and Preventive actions(CAPA), Design Controls, Risk Management Techniques, Supplier Corrective Action Develop Control Plans.

• Experienced in Validation and Verification activities for medical devices.

• Well-versed with Six Sigma concepts, Statistical Process Control, Design and Process Failure Mode and Effects Analysis(D/PFMEA) and Equipment and Process validations(Cp/ CpK, PpK, GR&R, Correlation) Hindustan Shipyard Limited Visakhapatnam, India

Internship December 2012-January 2013

• Knowledge of process of ship building and repair.

• Design and construction in areas of ships and submarines.

• Involved in production, planning and control activities.

• Involved in various departments like HULL SHOP, Pre- Fabrication, Erection and Engineering department.

• Involved in plate treatment like hydro leveler, heating, paint spraying and drying

• Experienced in cutting process like gas, flame and arc cutting.

• Close encounter working with various machines like Cranes, Hydraulic Press, Hydraulic Bending machine, CNC ( Computerized Numerical Control ), PMC ( Plasma Metal Cutting ), Robotic Cutting machine.

• Working knowledge of manufacturing of Hatch Covers and Side shells.

• Experienced in ARC welding process like Shielded Metal Arc welding, Gas metal Arc welding, Submerged Arc welding.

• Involved in the team working with manufacturing of Rudder and Anchor .

• Ability to read blueprint drawings.

PROJECTS

Software project: “Website Design and Development” Undergraduate Project: “Dynamic load analysis of four stroke single cylinder diesel engine crankshaft”

• Crankshaft is designed using CATIA and the maximum load before the breakpoint that the crankshaft in four stroke single cylinder engine is determined by applying various load using software ANSYS.

• The crankshaft is used in the power production mechanism inside the single cylinder with four stroke diesel engine

• By the end of the test the maximum load that a cast iron material made crankshaft is determined.

• Worked with Simulation and applying loads using Finite Element Model in ANSYS

• Calculating and analysing stress variations, effect of torsion and bending loads.

• Applying and comparing the stress variations and maximum loads for different materials.

"Latest trends in automobiles "

• Knowledge in various hybrid vehicles like mild hybrids, fuel hybrids, plug in hybrids (PHEVs), extended – range hybrids.

• Various hybrid vehicle types- two wheeled vehicles and cycles, hybrid cars and buses.

• In-depth knowledge in advantages and disadvantages of parallel, series and full hybrid vehicles.

• Various methods to Increase the Energy in hybrid vehicles.

" Robotic Workshop"

• Built a feedback control loop to control the robot and make it successfully balance while following the line.

• Arduino-based robot that utilizes an infrared sensor to follow a black line

• Two-member team project

• Design, build, and implement a robot using microcontroller.

• Surpassed original design proposal by making a shortest path algorithm Graduate project: " Front wheel Steering system with moveable headlights "

• Increasing the light angle efficiency for cornering by introducing the modern directional headlights using cam- follower, spring and gear mechanisms

• Methods to improves the Safety of automobiles and minimizing harmful effects.

• Close encounter with various gears and mechanisms, Sprockets, Chain Drive and Light Brackets.

• Conclusions include advantages and disadvantages of using the Steering Controlled headlights Quality Engineer: " Manufacturing of medical equipment "

• Determine the root cause and corrective actions for process failures using Fishbone diagrams, FMEA, Gauge R &R analysis and other statistical tools.

• Assists in investigations associated with Out-of-Specifications(OOS) and Non-conforming material reports

(NCMR), Deviations, CAPA, Supplier Corrective Action Reports (SCARs)

• Implemented the design change process by evaluating the impact on product design, documentation, production

& process controls and design transfer.

• Ensured internal quality process, procedures, all process validation requirements are met for all new and existing processes.

• Involved in developing all design control risk management documents such as plans, hazard analyses, and design and process FMEA, and reports

• Superior knowledge in risk assessment, 21 CFR Part 11 assessment and lab study reports.



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