Quality Engineer Assurance
Resume:
Francis M. Vaccarella
Springfield, TN 37172
Cell phone: 615-***-****
E-mail: *******.**********@*****.***
SUMMARY OF QUALIFICATIONS and EXPERIENCE
Aerospace, 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 Experience
Processes/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 and
airframe 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 and
assembly]
• 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 systems
Agricultural Equipment
Customers Serviced
• Abbott Labs, Boeing, GE, Grumman, Gulfstream, Hughes Helicopter, Lockheed-Martin, Northrop Grumman, Pratt and
Whitney, Sikorsky, Rolls Royce, John Deere, Zimmer Medical Equipment Co, Stryker Instruments, Hill-Rom, Synthes
Anspach
• 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]
EXPERIENCE
TASC Technical Services Dec 2014-present
Supplier Quality Assurance Engineer/ Representative [contract to Northrop-Grumman, B2 programme]
Supplier site quality assurance
Process compliance, lesson learned documentation and incorporation into planning, corrective action determination and implementation
First article inspection and AS9100/AS9102 requirements
Complete, in-depth knowledge of NGC SQAR manual and NGC tooling manual
Assisted in first article inspection, surveillance, tool proofing, and tool certification
Black 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 environment
Developed, 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 analysis
Used and evaluated various types of measuring and test equipment, utilizing Gage R & R techniques and Minitab
New Era Recruiting May 2014-Sept 2014
Quality 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 environment
Coordinated 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 CAPA’s
Facilitated and/or participated in root cause analysis while working with the Engineering group investigation during the complaint investigations
EHD Technologies Sept 2013-May 2014
Supplier Quality Engineer [contract to Unipres, Portland, TN]
• Acted as a supplier quality engineer to Unipres, on behalf of Nissan, in a TS 16949 environment
Reviewed supplier PPAP submissions, including FMEAs, control plans, Gage R & R, SPC, and material certs.
• Vehicle areas covered included: Chassis (assembly and sub-assembly) and Structures
Volt Management Group Mar 2013-Sept 2013
Quality 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 SAP
Accomplished internal quality audits as needed
American Contract Group Jun 2012-Mar 2013
Quality 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 medical
device components.
Investigated component and process non-conformances in a CNC machine environment.
Compiled and analyzed data, reconciled internal audits, and developed corrective and preventive measures
Participated in OQ and PQ activities
Supported 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 2012
Quality 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 validation
Participated in OQ and PQ activities
• Assessed the regulatory risk associated with change documents as well as processes and products
Utilized 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 2012
Quality 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 environment
Reviewed and wrote Deere Design and Process FMEAs pertinent to Harvester products
Reviewed supplier PPAP submissions, including FMEAs, control plans, Gage R & R, SPC, and material certs.
Reviewed and evaluated warranty information for trends and proper classification
Investigated quality related issues and recommended changes to engineering drawings
Assisted in warranty information reviews and investigations
Foster Design Mar 2010-Aug 2011
Quality 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 G650
structures.
• 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 Management
Systems
Volt Services Group Aug 2009- Mar 2010
Quality 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; inspection
oversight; 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 2009
Quality 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 820
environment
• 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 various
databases.
• 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 activities
Volt Services Group Feb. 2007-Sept 2007
Quality 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 manufacturing
capability 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 2007
Program 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 as
well as the demands of “black box” program.
Volt Services Group Jul 2006-Oct 2006
Quality Engineer [contract to Rolls Royce Energy, OH]
Developed, modified, applied, and maintained quality standards and evaluation methods for products and processes in compliance to
AS 9100/AS 9102, and ISO 9000.
Peak Technical Nov 2005-Jul 2006
Supplier 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 2005
Quality/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 assembly
environment which conformed to AS9100/AS9102, 14 CFR 21, and military specifications.
EHD Technologies, LLC Sept 2003-Nov 2004
Quality Assurance Consultant [contract to various clients]
• Consultant to various clients for quality assurance compliance, conformance, documentation, and program management
14 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 and
assembly, injection molded details and assembly, forgings (aluminum and steel); aerocraft electrical systems; aerocraft structures
Aerotek 1999- 2003
Supplier 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 Paint
Quality 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 customers
Supplier 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 1998–1999
Acting Supplier Quality Manager [contract with AP Automotive Systems, Toledo, OH; OEM, exhaust systems, QS 9000]
JACKSON AUTOMOTIVE GROUP, Jackson, MI 1992-1998
Quality engineer (QS 9000, Q-1, Military contracts; OEM Stampings, castings and forgings, injection moldings, and assemblies)
GEM TOOL & DIE, Detroit, MI 1982-1992
Quality 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 1977-1982
Depot Level, Structures Mechanic Overhaul & Repair, 3rd Shift Supervisor and Trainer
EDUCATION
UNIVERSITY OF MICHIGAN
• BA [business]- 1994
MILITARY SERVICE
• Air Force, 1971-1977; honorable discharge; wounded, decorated
TRAINING and CERTIFICATIONS
• Jump traiming, US Air Force, 1971
• Leadership Training, US Air Force, 1971
Combat medical training, US. Air Force, 1971
Airframe Repair, US Air Force, 1973
• ASQ, Certified Quality Technician, 1987
• ASQ, Certified Quality Engineer, 1989 (CQE is current)
• Journeyman’s 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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