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Quality Engineer Resume

New Jersy, NJ

Professional Summary:


Over 5 years of experience in Manufacturing, Quality & Design of Medical Devices on software & hardware Verification & Validation, testing, C programming on embedded system development ,Quality & Engineering Development on Class II/III Medical Devices.

  • Participate in hardware design Input / Output, verification, Testing & debug of highly integrated design applications, Compliance testing, Design History file, Acceptance criteria.
  • Pivotal in initiating, planning, execution, ensuring the integrity of production & Development, tracking / monitoring, controlling and completing projects as scheduled operational processes for increased efficiency, Distributing operation while maintaining productivity, reducing cost & wastage, optimizing resource utilization.
  • Implement new Technology from our Joint Venture companies for Development in our unit in Co-ordination with R&D & Venders.
  • Strong Analytical Skills, ability to define problem with Strategic planning, collect Statistical data, root cause Analysis, establish facts and Draw conclusions & controlling process rejections & achieve cost reduction with corrective actions (CAPA), Applied statistical analysis to complaint trending/tracking and conceptualizing on various reports.
  • Responsible for the organization, which encompasses on zero defect products to the customer\'s Requirements & Specification, continuous improvement in process & product quality & manufacturing using Lean & Six sigma principals. Ensuring Products Quality according to customers’ Requirements & Specification, Handling customer’s complaint & feedback.
  • Applied the manufacturing quality toolset including PFMEA, IQ, OQ, PQ, control plans, Process verification/validation plans, validation protocol development, SPC, hard gauging applications, computer-based inspection methods, operator work instructions, DOE, process data analysis, and DMAIC.
  • Technical Documentation like Work Instruction, Bill of Materials, Technical write up, DHR, Test Procedures, Tracking of Design changes & ECN, respective change in procurement & approve Deviation.
  • Implementing inventory control measures for diminishing obsolete stock keep tab on slow-moving Item and achieve reduction in inventory management cost.
  • Design and Process Risk Management Activities (Tools including FMEA, & FTA), Material Requirement Planning(MRP), Vendor Work order, Production Planning (PP), Purchase order for critical Items, consumption & Rejection Analysis through Ramco ERP Modules.
  • Co-ordinate for audits from FDA, ISO 13485-2003 & ISO 14971, CE, MDD, UL, TUV the external agencies & Internal Audit .
  • Expertise in application of Different modules of ERP System ( Ramco and Omnify) .

WORK EXPERIENCE: -

Confidential,OCT 2007 - JULY 2011 (3.9 Years)
Project : Percutaneous Transluminal Coronary Angioplasty
Designation :- Development Quality Engineer

  • Development Engineer in PTCA Balloon Catheter with the Team of M/s Interface catheter solutions, USA.
  • Established New Product Development (NPD) protocols, reports, procedures, specifications and systems to provide QSR / ISO compliance ,Design change , verification & Validation, data analysis, experimental design, process improvement/optimization, quality control, mathematical statistics, linear statistical models Trouble Shooting process parameters, calibration and PM documents, Inspection procedures, Production Planning & Protocol .
  • Clinical PMA trials 510(K), Bio-Analysis & Testing criteria as per ISO 13485 & FDA 21CFR 820 standards.

Project : Patient Monitoring System
Client : - Confidential,(USA) , Confidential,(USA),

Description : Technical Engineer
  • Testing of different Vital Biological parameters Like Spo2 , ECG, Temperature , IBP , NIBP using different Simulator and Parameter setting & Mode .
  • Design Jig Fixtures to load software (HEX FILE ) into Microcontroller & testing of PCB’s required to monitor signals like SPO2, BPM, & NIBP, ECG, temperature Etc Debugging of PCB’s Assy & Rework, IPC Electrical standards.
  • Inspection & Performance Testing of Medical Electronics devices & several safety test like Hipot Test ( 4 KV), Leak Current Test for devices, EMI/EMC testing , ISO 14971, IEC/UL 60601-1 3rd Edition & IEEE Standards, 21 CFR 820 .
  • Prepared Pilot and Validation report, Validate BOMs, drawings and procedures, Lot Travelers. Improved product designed by writing Engineering Change Notifications (ECN or ECO), Tracking of Design changes and respective change in procurement IGI & Yield Report .
  • Process control & Analyzing process problems using SPC standards, 8-D, 5-whys, Fishbone Diagram .
  • Investigated alternate components to improve quality / reliability, reduce costs to maintain operational efficiencies.
  • Ensure Product performance analysis , Risk Management, failure mode and effects analysis, essential requirements checklist, design verification / validation, design transfer to manufacturing, documentation completion tracking, and product release authorization for distribution of product Reviewed several engineering specifications, drawings, procedures, protocols and reports for compliance to quality requirements.
  • In charge - Calibration of test and measuring for all type of equipment’s/instruments.
  • Investigated and documented product complaints and in the subsequent rolling over of complaint data into corresponding FMEA’s.
  • Assisted sister-manufacturing sites with the interpretation of quality requirements including verification/validation planning and execution, first production run requirements, and problem resolution.
  • Assisted in resolving quality complaints from manufacturing aspects,trained operators and technicians with new tools, machines, fixtures and processes.
  • Initiated and Proceeded validation (IQ, OQ and PQ) protocols, assisted in creating Master Validation plans equipment .
  • Worked on Software Validation & Verification based on Specification, Testing and Release Phases on various type of application.
  • Developed test fixtures for incoming inspection & PCB’s IEEE testing which measures Spo2, ECG, NIBP, etc.
  • Cycle Time Reduction-Inspection & Continuous improvement projects.

Project Guide -: Designated as Project Guide for UG final Semester Engineering project at M/s Opto Circuits (I) Ltd

Confidential,APR 2007 – OCT 2007

Service Engineer handling Customer complaints. Customerservice& compliance covering Installations, Repairs, Maintenance, Upgrades, Troubleshooting & Software installations on medical devices like Infusion Pumps Syringe Pumps, Multi parameter monitor with Quality Assurance.

Confidential,JAN 2007- APR 2007
ECG SIMULATOR TO BED SIDE MONITORING SYSTEM
The project aims to generation of ECG signal and other arrhythmia condition which is used in compare the ECG of the patient then depending on the condition appropriate result is displayed on bed side monitoring system.

  • It includes a programmed microcontroller that generates the ECG signal and other arrhythmia condition ie Normal ECG ,Sinus Bradycardia, Sinus Tachycardia, Hypertrophy, Mitral Stenosis , ST elevation, AV block.
  • It also compares these conditions with the patients ECG and gives the suitable results with different beep.

Education Qualification : Bachelor of Engineering in Medical Electronics

Software Skills:
Operating System : MS-DOS, Windows98/2000/ XP/Windows 7, MS Office .
Programing Languages : C, C++, 8085/8086, MATLAB, Java Script, Visual Basic 6.0,Lab view, Java, HTML
DBMS : SQL, ERP ( Ramco), MS Access.

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