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Quality Assurance

Clifton, New Jersey, United States
October 19, 2016

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*** ****** ******, ******* ** *****-****

PH: 973-***-****(H); 973-***-****(M)

Dear Sir / Madam:

I am ASQ Certified Quality Engineer (CQE), presently working as an independent consultant for various medical device companies. Formerly, I was governing Quality Management System (QMS) at BLICKMAN Health Industry, Clifton, New Jersey as a Director, Design-Quality Assurance Engineering and Technical services as well as an appointed Management Representative. All along, I am very much involved with high precision, high volume complex component/assembly manufacturing for Aerospace, Defense, and Automotive Industries so as special/dedicated machine building for communication and Medical Device manufactures. My major responsibilities includes: Quality system institution, Contract review, design review, build prototype, design verification, product evaluation in terms of manufacturability (DFM), Advance Quality Planning, Selection and use of applicable QA Standards, Internal Audit, Continuous Improvement, Training, Corrective Action, and Preventive Action. In addition, I am also responsible for process validation in order to ensure that a specific process or an equipment will consistently produce a product meeting its predetermined specifications and quality attributes using Statistical Process Control and validation techniques such as DQ,IQ,OQ,PQ,MQ.

Employing knowledge base applications and implementing unique procedures, we have succeeded in reducing production “X” hours by eliminating unnecessary papers bung and yet comply with ISO/AS/QS/FDA/EPA/OSHA requirements. We were able to derive quality concept “MAKE IT RIGHT THE FIRST TIME” from inspection room to the manufacturing floor through close coordination engineering. I fervently believe that quality needs to be built in to design and to production processes. With the concept of Total Quality Management providing Dock-to-Stock products, we succeeded in accomplishing the preferred/certified supplier status for the major Aerospace, Defense, Automotive, and Medical Device companies/distributors. I will highly appreciate, if you will consider me for this opportunity and arrange for an interview.


Pragnesh Desai


Pragnesh Desai 235 DeMott Ave. Clifton, NJ 07011 Ph: +1-973-***-**** Objective Acquire a challenging Engineering position with a progressive organization by enhancing Design, Process, and Quality to increase Productivity. Employment


Aero Manufacturing, PMMI, Interplex NAS, AmMed, Oshaka Medical etc. NJ Independent Consultant (Oct. 2014 – Present)

Blickman Health Ind. Clifton, NJ

Director; Design & Quality Assurance Engineering / MR, (Mar. 2006 – Oct. 2014) Precision Magnetics (Formerly Magnaquench) Wayne, NJ Quality Assurance Manager / MR (Jan. 2003 – Mar. 2006) Triad Tool & Die Hillside, NJ

Quality Assurance Manager / MR (Oct. 1988 – Jun. 1993 & Nov. 1999 – Jan. 2003) Arlington Machine & Tool Fairfield, NJ

Quality Assurance Manager / MR (Jul. 1996 – Nov. 1999) American Product Company Union, NJ

Quality Assurance Manager (Jun. 1993 – Jul. 1996)

Dewey Electronics, Inc. Oakland, NJ

CMM Programmer (Apr. 1985 – Oct. 1988)

Experience § Serve as Management Representative and as Lead Internal Auditor, report QMS performance findings in a summary format that provides executive management proper insights in to deficit areas. Transpire as a liaison with external parties on quality matters.

§ Commence QS9000 / AS9100 / ISO9001 / ISO13485 / TS16949 certification process: Review / Revise Quality policy Manual; Prepare processed based Check lists for Internal Audit; Develop Master Plan for Implementation, Prepare System Level Procedures (SLP), Flow charts, Work Instruction and Technical Documentation.

§ Maintain elements of corrective and preventive action system. Initiate corrective action based on quantifiable data and Monitor follow-up through closure of all CARs.

§ Prepare, review and revise User Requirements Specification (URS) by identifying product safety, identity, conformance, function, performance, durability, dependability, and serviceability parameters.

§ Transform all plain paper quality forms in to database records, using customize query furnish real-time reports, and maintain all quality records electronically (paperless), Improvise d-base solution to ISO/AS/QS requirements.

§ Develop distinctive program to control measurement and test equipment (Calibration), which includes Measurement System Analysis (MSA, Gage R&R).

§ Determine most appropriate control methods to monitor Key Process and/or Key Product characteristic during manufacturing operations through incorporation in the Control / Quality Plan.

§ MRB analysis and disposition of the Parts and Gages, Analyzing virtual fit conditions using drawing data and actual.

§ Investigate and Conform manufacturing feasibility of proposed product for the suitability of a particular design, material, or process for production, considering stated engineering requirements and statistical process capability at specified volume.

§ Promote Documented Training Program, Vendor Certification program (Quality, Cost, Delivery, and Capability), Continuous Improvement and Non-conforming Reaction Plan.

§ Simplify Engineering Change Order (ECO), Production Plan Approval Process (PPAP), Initial Submittal Inspection requirement (ISIR) and Process Change Approval (PCA).

§ Perform Tolerance Stack-up Analysis for assemblies. Page 1 of 2

§ Support design/manufacturing engineering by employing technique such as Design of experiments (DOE), Failure Mode and Effect Analysis (FMEA) and Statistical Process Monitoring (Variation, Control, Capability, over adjustment etc.) to accomplish process improvements.

§ Integrate Sheffield and B&S (Direct Inspect, Measure-Max, PCDIMS) CMMs with MS Office applications (Smart Report) and enlighten technicians in CMM programming.

§ Establishment and Maintenance of an Inspection Systems IAW MIL-I-45208A and Calibration System IAW MIL-STD-45662A.

§ CMM'S Programming: Sheffield (Direct Inspect, Measure-Max, OFI, FLB), DEA (Tutor P), B&S (PCDIMS) and MITUTOYO (Micropak, Geopak)

§ Interpret and explain ANSI Y14.5 GD&T, NADCAP PD1000, Mil-std, DOD std. FAR clauses, NAVSEA specification, DFAS regulation, cGMP/QS regulation, CDRH/ASTM standard, and QPL requirements.

§ Assist in design and modification of Jigs and Fixtures.

§ Collect and analyze Inspection data to establish Quality level using Sampling Inspection along with Control Charts. (ANSI Z1.4/MIL-STD-105, ANSI Z1.9/MIL-STD-414).

§ Identify Cause, Initiate Corrective Action, Request (QDR) or Reply (8 D'S, 4 D'S) Corrective Action.

§ Conduct Process Capability Study of the CNC Machining Centers.

§ Inspect, explore and review First Article / Layout Inspection.

§ Analyze traditional inspection method versus unconventional methods (w/CMM) and replace expensive Positional Functional (metal) Gages with Soft-gages.

§ Select most appropriate inspection method for a part feature.

§ Functional gages design, Assign Gage Wear Allowance. Education

Bangalore University, Bangalore, India

§ B. S. Production Engineering, 1984.

New Jersey Institute of Technology, Newark

§ Acquired 12/36 credits towards M. S. Industrial Engineering. STAT-A-MATRIX Institute, Edison, NJ

§ “Lead Auditor Certification” ISO 9000 Registered, 1999. American Society for Quality (ASQ)

§ “Certified Quality Engineer” (CQE), 2001


Software: Proficient in AutoCAD, SolidWorks, COSMOS, PCDIMS, Direct Inspect, Measure Max, Image, Pro-Engineer, WordPerfect, MS Access, MS Excel, MS Word, MS PowerPoint, MS Outlook, ACT, ABC Flowchart, Internet Explorer, Netscape Navigator, ProGage, Toculator (CATA), Gage R&R, MiniTab, Softgage, SPCPRO, PofitKey, JobBoss, MACOLA, ORACLE…

Language: Visual Basic, SQL, PL/SQL, HTML, Deapple, FLB, OFI, DIMS Operating System: Dos, Windows ’95, ’98, 2000, ‘7, ‘10, NT, XP, OS2, Unix, MacOS X Achievement Ø Developed Object Oriented Off-line Part Program Generating software for the CMM. (1992).

Ø Reengineered Blickmans’ entire “MR Safe” product line making conforms to latest ASTM standards F2503, F2052 and F2213 related to patient safety in Magnetic Resonance Environments (2008).

Ø Designed, developed, and patented a cost-effective All-In-One Ambulatory/bedside device for post-surgical patient to reduce recovery time.

(U.S. Patent No. 62/189,563 and U.S. Patent No. 29/532,485) Reference

Available upon request. U.S. Citizen

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