NILESH PATEL

** ******** ***.,

Livingston, NJ - 07039

201-***-****

acyhu1@r.postjobfree.com:acyhu1@r.postjobfree.com

acyhu1@r.postjobfree.com

SUMMARY

Quality Assurance and Manufacturing Professional experienced in Aerospace, Defense, and Health Care industry, currently working as Validation Engineer.

●Experience with ISO 9001, AS9100, ISO 13485, Internal Audit, TIP QA, SQL, Minitab, SAS (Data Acquisition and Data Management, Data Analysis), TrackWise, Autodesk PLM360. Software based Instron MT Series Torsion Testing

●ASQ Certified Quality Engineer (CQE) and current member of ASQ

●Member of MRB, and CAPA Boards, QA Reviewer for Verification and Validation Test Plans, Component Specs, Standards, Drawings, ECNs

●Familiar/Certified with NHB5300.4 (3A-1), IPC J-STD-001E and IPC-610/620 Soldering, FDA 21 CFR Part 820, 876, Workmanship and Assembly standards, ESD

●Expertise in generating customized tables, listing, analysis and reporting tools

●Experience in Software and Instruments validation process

●Trained Assemblers, Technicians and Quality Control Personals

●Excellent Supervisory skills to work with people at all levels in highly regulated manufacturing plant

PROFESSIONAL EXPERIENCE:

Siemens (Consultant) Validation Engineer

(Health Care -Diagnostics) (Nov. 2015 – Jan 2017)

●Member of Global New Product Development Group

●Developed Test Plans, Test Procedure, and Test Cases for IQ, OQ and PQ of various GNPD Test Equipment

●Developed Verification Plan, Verification Protocols, Verification Summary report for various GNPD Test Equipment

●Involved in Tester Software Validation using MS-TFS, and MTM

●Supported Data Analyst Activities focused on Equipment and Process Validation using Minitab

●Involved in Test plan integration of various Instrument and Test Equipment for GNPD

●Created and organized Test Plans, and executed manual tests using Microsoft Test Manager(MTM)

●Developed Requirement and Test Cases in MS-Team Foundation Server

●Approved fixtures, tools and test procedures for pilot run to be phased into Production Line

●Integrated R & D requirements in to Tester Functional Specification for GNPD Test Equipment

●Supported Test Equipment and Test Process validation by participating in the development of studies and validation protocols to assess manufacturing capability/reliability as a part of GMP

●Maintained Traceability matrix for product validation and R & D requirements

PENTAX Medical, Montvale, NJ (Consultant) Quality Engineer

(Medical Device Manufacturer) (Dec. 2014 – Oct. 2015)

●Created Supply Chain Qualification documents including Incoming Inspection Procedures, Travelers, Supplier Qualification Metrics, Supplier Corrective Action Request Form (SCAR), Supplier Score Card, and Supplier Audit Check List

●Implemented Critical Process Validation protocols as a part of GMP in the medical device

●Performed quality failure investigations (FMEA activities)in compliance with FDA regulations (FDA 21 CFR Part 820) and corporate reporting requirements

●Maintained instructions and procedures written in clear and unambiguous language as a part of Good Documentation Practice

●Provided support to the manufacturing to resolve quality issues of New Product Release.

●Participated in Process/Design Failure Mode and Effects Analysis (PFMEA /DFMEA) for newly developed Endoscope with instrument channel.

L3 Communications, Budd Lake, NJ. Quality Engineer

(Space & Navigation Division) (Aug. 2007 – Nov. 2014)

●Developed test plan, First Article Inspection Instruction and executed process validation protocols for various computerized lab /production equipment

●Participated in Product safety and Reliability activities.

● Prepared Process Progress Reports, using Product Lifecycle Management Autodesk PLM 360

●Analyzed Product Performance Trends for Ring Laser Gyros using Minitab

●Suggested necessary steps/check points in test software to improve the test procedure and quality of product by using better Select At Test components

●Recommended improvement steps for test methods based on SPC results for achieving required levels of product reliability.

●Supported Data Analyst Activities focused on process optimization, process yields, inventory optimization, resource utilization, with enhancement of JIT

●Developed test procedure for Cable and Harness testing using Instron MT series Torsion Tester.

●Maintain Statistical Process Control for Inertial Sensor Assembly (ISA)

●Team Leader for Product Quality Support (PQS) and System Reliability Testing

●API test integrations with a closed set of distributed systems among several Test Fixtures

●Worked with cross-functional teams to investigate and resolve quality problems

●Member MRB, and CAPA Board

HoneyWell, Teterboro, NJ. Quality Engineer

(Aero-Space Division) (May 2000 – Aug. 2007)

●Provided assembly technique data to improve quality and reliability

●Converted customer requirements into the Specification during Design Phase

●Developed and Implemented Acceptance and Environment Test Plans

●Designed Test and Quality Procedure to verify reliability and accuracy of product

●Integrated Test plan of Momentum Wheel Assemblies, and Reaction Wheel assemblies as per NASA’s specifications, with QC, Manufacturing, and Engineering

●Specified Corrective and Preventive Action procedures for minimizing rejection, and better Product Quality (CAPA)

●Integrated Capability Performance testing of various test, and manufacturing equipment

●Developed integrated Quality Testing/Inspecting of HIMARS (High Mobility Armored Rocket System) gyros units, using TIP QA

●Supported manufacturing activities focused on process optimization. process yields, inventory optimization, resource utilization etc., using Lean Manufacturing tools

Allied Signals, Teterboro, NJ. Validation Engineer

(Guidance and Control System Division) (1995- 2000)

●Developed test plan and executed Process Validation Protocol for various computerized test equipment

●Assisted manufacturing to select the appropriate procedure based on the SPC result, to improve Cycle Time and Productivity

●Provided technical support and developed IQ (Installation Qualification), OQ (Operational Qualification), PQ (Processes Qualification) of various Test and Production Equipment

●Responsible for Verification and Validation of various test procedures

●Coordinated activities to finalize Product Workbook, technical issues with customer

●Conducted Process Capabilities studies to develop Process Control Plan

●Incorporated preventive maintenance schedule to meet ISO 9000 certification requirements

●Approved fixtures, tools and test for pilot run to be phased into Production Line

●Analyzed and took corrective actions of test procedures using FMEA technique

Computer Systems Inc., Secaucus, N.J. Production Engineer (Computer Hardware & Peripheral manufacturer) (1994 - 1995)

●Redefined operating procedures using Single Minute Exchange of Dies (SMED) for assembly line workers, which reduced Cycle Time by 7 %

●Coordinated the procurement and assembly activities for new products

●Provided assembly techniques to improve quality and reliability

●Analyzed manufacturing, and test data to evaluate process performance

●Involved in modification of tools/fixtures and redesigned the manufacturing techniques that resulted in scrap reduction

●Implemented Lean Manufacturing concepts to reduce the Cycle Time, and machine down time

●Performed required tests while applying quality control standard to comply with customer’s specification

EDUCATION:

Bachelor of Science in Electrical Engineering

New Jersey Institute of Technology, Newark, NJ

Associate Degree in Mechanical Engineering.

M. S. University, Vadodara, India.

ASQ Certified Quality Engineer (CQE).

COMPUTER SKILLS:

Software Package: MS Office Tools, Visio, Solid Works. LabView, Matlab, Minitab, SAS, Tip QA, MS-Team Foundation Server, MTM, SAP, Autodesk PLM 360

Languages: Visual Basic, HTML, C

Database Tools: Oracle 7.x, MS Access, PL/SQL

TRAINING / AWARDS:

●ASQ Certified Quality Engineer (CQE)

●Completed 6-Sigma Green Belt Training

●Recipient of National Merit Scholarship, India

●University merit listed in the Diploma

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