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Title Quality Engineer Assurance
Target Location US-TN-Cross Plains
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Street Address  Lamont Rd.Springfield, TN Street Address
Cell phone: PHONE NUMBER AVAILABLEE-mail: EMAIL AVAILABLESUMMARY OF QUALIFICATIONS and EXPERIENCEAerospace, Medical Equipment, Automotive, Commercial Certified Quality Engineer (CQE), Certified Quality Technician [CQT] Certified Process and Quality Auditor (Certified QMS auditor via SAI Global #79879 and via various clients) Supplier Quality Assurance CADAM, PCMM, Laser Tracker, AutoCad, Catia V5/ V6, Enovia, Solidworks, GD &T, SAP, MS Office, MS Project APQP, Contract Review, Design Review, SAP Assembly, stamping, welding, machining, composites, special processes ISO 13485; cGMP; AS9100/AS9102; title 14 part 21, part 25, and part 145; ISO9000; TS16949; 21 CFR 820 PPAP, PSO, GP12, First Article, ISW Control plans, PFMEAs, DFMEAs, Relentless Root Cause Analysis, DV P & R, CAPA, ISO 14971 SPC, Gage R & R, Process Certification, Mistake Proofing Project and Program Management ExperienceProcesses/Products Light, medium, and heavy stampings [aluminum, steel, and stainless steel] Welded assemblies [mig, tig, gas, and resistive weld] Machined products [aluminum, steel, stainless steel, specialty metals] Forgings and Castings [steel and aluminum] Tubing, bending and flaring [cold rolled steel, stainless steel, aluminum, copper, and brass] Exhaust systems-steel and stainless steel [parts manufacture and assembly] Braking systems-disk, drum, and ABS [parts manufacture and assembly] Steering systems [parts manufacture and assembly] Fuel systems-plastic and steel [parts manufacture and assembly] Structural systems-steel, aluminum, and composite; aerocraft and automotive [parts manufacture, chassis andairframe assembly] Body & White, SMC, and composite materials [parts manufacture and assembly, automotive and aerocraft] Front and rear suspension systems [parts manufacture and assembly] Powertrain-engine, transmission, and drivetrain [front and rear wheel drive, 4 wheel drive; parts manufacture andassembly] Interior trim [parts manufacture and assembly, automotive and aerocraft] Standard and CARC paint [part and assembly] Electrical [in a defence application as well as assembly in automotive and aerocraft seating environments] Carbonized heat treat Jet engine parts, assembly, and applications [military and commercial] Military and commercial aerocraft parts and assemblies Aerocraft and motor vehicle seating systems Joint Tactical Radio System [JTRS] Composite materials [aerospace and automotive] Medical diagnostic equipment, medical implants, and medical devices [Class II and Class III] Unmanned aircraft systemsAgricultural EquipmentCustomers Serviced Abbott Labs, Boeing, GE, Grumman, Gulfstream, Hughes Helicopter, Lockheed-Martin, Northrop Grumman, Pratt andWhitney, Sikorsky, Rolls Royce, John Deere, Zimmer Medical Equipment Co, Stryker Instruments, Hill-Rom, SynthesAnspach Mercedes-Benz, DaimlerChrysler, Ford, General Motors, Nissan, Toyota FAA and CAAI United States Armed Forces Contracting System The Israeli Defense Force [under the US Armed Forces Contracting System] General Dynamics Land Systems-Armored Vehicle Division Commemorative Air Force [under the FAA contracting system]EXPERIENCETASC Technical Services Dec 2014-presentSupplier Quality Assurance Engineer/ Representative [contract to Northrop-Grumman, B2 programme]Supplier site quality assuranceProcess compliance, lesson learned documentation and incorporation into planning, corrective action determination and implementationFirst article inspection and AS9100/AS9102 requirementsComplete, in-depth knowledge of NGC SQAR manual and NGC tooling manualAssisted in first article inspection, surveillance, tool proofing, and tool certificationBlack Diamond Network Sept 2014-Dec 2014 Quality Engineer [contract to Synthes Anspach, Palm Beach Gardens, FL]Supported the sustaining engineering efforts focused on the remediation for medical equipment in an ISO 13485, 21 CFR 820, cGMP environmentDeveloped, implemented, maintained, and improved gages and tooling/fixtures, to optimize quality, productivity and cost performance.Identified and implemented corrective actions to resolve manufacturing process problems through testing, evaluation, and analysis.Helped prepare process FMEAs and root cause analysisUsed and evaluated various types of measuring and test equipment, utilizing Gage R & R techniques and MinitabNew Era Recruiting May 2014-Sept 2014Quality Engineer [contract to Hill-Rom, Batesville, IN]Supported the sustaining engineering efforts focused on the remediation of the post market complaint investigations for medical equipment in an ISO 13485, 21 CFR 820, ISO 14971, cGMP environmentCoordinated and completed the documentation required for the closure of the post market complaint investigations.Supported the activities required to ensure the investigations are in conformance with FDA requirements.Completed the non-conforming evaluations for the determination of recommendation of CAPAsFacilitated and/or participated in root cause analysis while working with the Engineering group investigation during the complaint investigationsEHD Technologies Sept 2013-May 2014Supplier Quality Engineer [contract to Unipres, Portland, TN] Acted as a supplier quality engineer to Unipres, on behalf of Nissan, in a TS 16949 environmentReviewed supplier PPAP submissions, including FMEAs, control plans, Gage R & R, SPC, and material certs. Vehicle areas covered included: Chassis (assembly and sub-assembly) and StructuresVolt Management Group Mar 2013-Sept 2013Quality Engineer/ MFG Plan Auditor [contract to Triumph Aerostructures, Stuart, FL] Worked as a quality engineer, manufacturing planner and auditor in an AS9100/AS9102 environment for KC-46 [767 tanker]structures. Prepared AS9102 documentation for wing box and wing box structure for the initial structural designs. Utilised MEDS and SAP to accomplish assigned AS9102 tasks Validated and edited quality and manufacturing plans against 3D Catia V5 models, MEDS, and SAPAccomplished internal quality audits as neededAmerican Contract Group Jun 2012-Mar 2013Quality Engineer [contract to Stryker Instruments Division, Kalamazoo, MI]* Maintained Quality Systems to comply with regulations 21 CFR 820, cGMP, ISO 14971, and ISO 13485 for the manufacture of medicaldevice components.Investigated component and process non-conformances in a CNC machine environment.Compiled and analyzed data, reconciled internal audits, and developed corrective and preventive measuresParticipated in OQ and PQ activitiesSupported internal layered process audits; a problem solving program that included root cause analysis and permanent corrective actions; shop wide control plans and associated electronic data collection that generated data for SPC analysis, validation, and the PPAP process.Oxford International Jan 2012-Jun 2012Quality Engineer [contract to Zimmer Medical Equipment Company, Warsaw, IN] Quality Assurance for various types of Class III Orthopaedic Implants in an ISO 13485, 21 CFR 820, ISO 14971, cGMP environment Responsible for implementing and maintaining supplier qualification/ disqualification, supplier monitoring, product validation, and process validationParticipated in OQ and PQ activities Assessed the regulatory risk associated with change documents as well as processes and productsUtilized comprehensive process knowledge and detailed understanding of multiple technologies in failure analysis, risk analysis, specification setting, engineering change/release process, lean manufacturing, and product development/improvement.Volt Services Group Aug 2011-Jan 2012Quality Engineer [contract to John Deere Harvester Division, East Moline, IL]Used quality planning tools to formulate and facilitate quality plans for new Harvester products in an ISO 9000 environmentReviewed and wrote Deere Design and Process FMEAs pertinent to Harvester productsReviewed supplier PPAP submissions, including FMEAs, control plans, Gage R & R, SPC, and material certs.Reviewed and evaluated warranty information for trends and proper classificationInvestigated quality related issues and recommended changes to engineering drawingsAssisted in warranty information reviews and investigationsFoster Design Mar 2010-Aug 2011Quality Engineer/ MFG Plan Auditor [contract to Spirit Aerosystems, Tulsa, OK] Worked as a quality engineer, manufacturing planner and auditor in an AS9100/AS9102/FAA environment on G250 and G650structures. Developed and administered directives, policies, processes and procedures to assure program/contract, company, customer / government,regulatory requirements, international standards, and working agreements were deployed. Conducted quality system/process reviews, provide customer interface, and ensured preventive and corrective action. Validated and edited manufacturing plans against 3D Catia models, Catia V5 and Enovia, using HMS Manufacturing ManagementSystemsVolt Services Group Aug 2009- Mar 2010Quality Engineer [contract to Insitu, Bingen, WA] Was responsible for assigned products and systems, from concept to repair and rework in an AS9100/AS9102/NAVAIR environment Conducted quality planning; pre-production reliability planning and data analysis; defect root cause analysis and follow-up; inspectionoversight; cost of quality analysis; supplier quality qualification and technical assistance; first article inspection; control of non-conforming products; quality documentation; peer review of designs, drawings, functional product specifications, etc.Manpower Professional Sept 2007-Aug 2009Quality Engineer [contract to Abbott Labs, Diagnostics Division, Irving, TX] Quality Assurance for various types of Class II medical diagnostic equipment in an ISO 13485, cGMP, and 21 CFR 820environment Responsible for implementing and maintaining the monthly Impact Assessment Score tool used to evaluate parts performance,performing effectiveness checks following implementation of CAPA Plans, and creating metrics from ad hoc queries of variousdatabases. Assessed the regulatory risk associated with change documents, defended rationale and compliance to internal and external auditors. Utilized comprehensive process knowledge and detailed understanding of multiple technologies in failure analysis, specification setting,engineering change/release process, lean manufacturing, and product development/improvement.* Participated in OQ and PQ activitiesVolt Services Group Feb. 2007-Sept 2007Quality Engineer [contract to AAR, Clearwater, FL]Worked with bid team and project engineers to define and document inspection and test processes and plans and ensure manufacturingcapability of composite product* Supported the redesign and implementation of the AAR quality system to conform to AS9100/AS 9102, 14 CFR 21 and 145,and military specifications, as necessary.Triad Worktec Oct 2006-Feb 2007Program Quality Assurance Systems Specialist [contract to Boeing IDS, Anaheim, CA] Program Quality Assurance for the Joint Tactical Radio Systems Program Designed, developed, and helped to implement a FRB/FRACAS activity that would accommodate engineering and production items aswell as the demands of black box program.Volt Services Group Jul 2006-Oct 2006Quality Engineer [contract to Rolls Royce Energy, OH]Developed, modified, applied, and maintained quality standards and evaluation methods for products and processes in compliance toAS 9100/AS 9102, and ISO 9000.Peak Technical Nov 2005-Jul 2006Supplier Quality Engineer [contract to Middle River Aircraft Systems, MD] Evaluated and examined supplier manufacturing and QA processes for compliance to AS 9100/AS 9102, 14 CFR 21 and 145,military, and commercial quality and process specifications for aerocraft parts and assemblies.Arnold-Hanafin, Corp. Nov 2004-Nov 2005Quality/Process Auditor [contract to Pratt & Whitney, CT] Responsible for the auditing of a wide range of manufacturing and quality processes within a jet engine manufacturing and assemblyenvironment which conformed to AS9100/AS9102, 14 CFR 21, and military specifications.EHD Technologies, LLC Sept 2003-Nov 2004Quality Assurance Consultant [contract to various clients] Consultant to various clients for quality assurance compliance, conformance, documentation, and program management14 CFR 21 and 145 [FAA], QS9000, ISO9000, AS9100/AS9102 Products included automotive welded exhaust systems (mufflers and cats), chassis parts and sub-assembly, cockpit details andassembly, injection molded details and assembly, forgings (aluminum and steel); aerocraft electrical systems; aerocraft structuresAerotek 1999- 2003Supplier Quality Engineer [contract to GM] Feb 2002-Sept 2003 Acted as a supplier quality engineer for the GM launch team on the following launches: the H2 Hummer, Cadillac XLR, Corvette C-6 Vehicle areas covered included: Chassis (assembly and sub-assembly), Powertrain, Exterior, Electrical, Interior, Structures,Forgings, and PaintQuality Engineer [contract with Hi-Lex, Battle Creek, MI] Aug. 2001- Feb. 2002 Acted as a quality engineer assembling and compiling information for PPAP and ISW packages for Hi-Lex customersSupplier Quality Engineer [contract with DaimlerChrysler, MI] Dec. 1999-Aug. 2001 Acted as supplier quality engineer for Chassis Engineering Group, 2002 KJ [Liberty] Jeep platform. Chassis Engineering Group included brake systems, fuel systems, cooling systems, exhaust systems, suspension systems,forgings, and structural systems (assembly and sub-assembly on all).Belcan TechServices, OH 19981999Acting Supplier Quality Manager [contract with AP Automotive Systems, Toledo, OH; OEM, exhaust systems, QS 9000]JACKSON AUTOMOTIVE GROUP, Jackson, MI 1992-1998Quality engineer (QS 9000, Q-1, Military contracts; OEM Stampings, castings and forgings, injection moldings, and assemblies)GEM TOOL & DIE, Detroit, MI 1982-1992Quality Manager/Program management (Q-101, Military, FAA; small machine parts; small and medium stampings, tools & dies)LEAR-SIEGLER MANAGEMENT SERVICES DIVISION, NAS San Diego, CA 1977-1982Depot Level, Structures Mechanic Overhaul & Repair, 3rd Shift Supervisor and TrainerEDUCATIONUNIVERSITY OF MICHIGAN BA [business]- 1994MILITARY SERVICE Air Force, 1971-1977; honorable discharge; wounded, decoratedTRAINING and CERTIFICATIONS Jump traiming, US Air Force, 1971 Leadership Training, US Air Force, 1971Combat medical training, US. Air Force, 1971Airframe Repair, US Air Force, 1973 ASQ, Certified Quality Technician, 1987 ASQ, Certified Quality Engineer, 1989 (CQE is current) Journeymans certification [tool & die] US Department of Labor, 1990 Certified Quality Auditor [QS9000], 1999 (certified by Chrysler)Certified Quality Auditor [AS9100], 2005 (certified by Pratt & Whitney) ;Certified Quality Auditor [AS9100], 2006 (certified by GE);Certified RABQSA AS 9100 Standard Auditor, 2007 (certified by SAI Global, cert. # 79879)Certified Quality Auditor [AS9100], 2010 (certified by Spirit);Certified Quality Auditor [ISO9000], 2011 (certified by Deere)Certified Validation Specialist [ISO 13485/ 21 CFR 820], 2012 (certified by Zimmer)Certified Level II Validation Specialist [ISO 13485/ 21 CFR 820], 2013 (certified by Stryker)Certified Quality Auditor [AS 9100], 2013 (certified by Vought)

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