ERGIN “Ed” GURBUZ

Allen, TX *****

214-***-**** cell

OBJECTIVE

In high-tech industries quality assurance/control manager or director, senior QMS lead auditor, senior quality engineering, and supplier quality management positions utilizing my expert technical and bilingual skills in aerospace, oil & gas, medical device, and information systems companies.

QUALIFICATIONS

Over twenty-five years of hands-on expertise in high-tech industries with solid engineering and management skills with technical abilities, continuous growth and increased responsibilities in medical field (Abbott, FM Global, DEVA) and aerospace (Boeing, Lockheed Martin, Raytheon, Hamilton Sundstrand, and Northrop Grumman) involving flight hydraulic systems, electro-mechanical, flight deck electronics, mechanical comprehension, communication systems, technology transfers also many years in high energy physics (DOE national laboratories) putting together new Superconducting Super Collider (SSC) project, and also experience in oil & gas, medical device (Abbott), and electro-optical (Northrop Grumman) fields. Solid involvement in design & manufacturing fields in Fortune 500 companies includes: Quality Management Systems, AS 9100, ISO 9000, ISO 9001, ISO 9002, D1-9000, NQA-1, MIL-Q-9858, NADCAP, Internal and Global Quality Systems Lead Auditing, New Business Developments, Embedded System Testing including firmware and software, Test Qualification Audits, Technology Transfers, Project Engineering and Management, Procurement Quality Assurance and Supply Chain Management, Member of Material Review Board (MRB), Configuration Management, 8D corrective actions, Lean Manufacturing, Kaizen, fabrication/welding, 5S & 6S, Statistical Process Control, VISIO, Six Sigma, Geometric Dimensioning and Tolerancing (GD&T), Gage R&R, pro-CAD and Quality Reviews of engineering drawings, acceptance test/validation procedures, safety of flight and qualification test documents, FAI, source inspection involving intercontinental and global suppliers, receiving inspection and testing of assemblies and products, company ISO or FAA audit preparations and obtaining certifications.

Working knowledge of Windows-based software including MS Internet, MS Power Point, MS Word, MS Excel, MS Visio, MS Outlook and Net-Inspect. Also familiar with Mac, Oracle, Matrix and Baan programs. Bilingual; fluent in Turkish and English. US citizen with present security clearances.

PROFESSIONAL CERTIFICATIONS

AS 9100 and ISO 9000 Lead Auditor, ASQC Energy Division Lead Auditor, eighteen (18) years of Certified Quality Engineer (CQE), six (6) years of RAB certified QMS auditor, and Boeing D1-9000 Lead Auditor. Recently certified for Title 21-Food and Drug, Abbott Diagnostics Clinical Chemistry, MDTX-Top Engineering Essentials for MD Technology, ISO 13485-2016 MD-Quality Management System, ISO 14969, ISO 9001-2015-Quality Mgt Sys-Requirements, SOR 98-282 MD Regulations 2019-01-30, 21 CFR Part 820, ISO 14971-2007 MD-Risk Mgt.

EDUCATION

MA, Information Systems Management, Webster University, St Louis, Missouri, 1988.

MA, Human Resources Development, Webster University, St. Louis, Missouri, 1988.

BS, Science-Biology, Chemistry, Physics, Istanbul University, Istanbul, Turkey.

MEMBERSHIPS

Member of American Society for Quality since 1983, currently upgraded to Senior Member status.

Lexington Who’s Who Registry for Executives and Professionals 1999/2000/2001, and 2014.

President of Turkish-American Association of North Texas 2011/2012 and current member of TURSOTX.

USSF State Soccer Referee 1983-2020 (Texas, Colorado, and Alaska)

PROFESSIONAL EXPERIENCE

Jan 2019 – May 2019

Abbott Diagnostics Division/Datamatics, Irving, TX Quality Engineer

Developed and maintained quality engineering methodologies and quality engineering in order to support Prism and Alinity production facilities and assemblies. Utilized quality engineering tools and techniques, validate testing of finished products, establish sampling plans and participated in production meetings. Went through intensive training including: 160 Abbott documents and instructional videos on medical diagnostics, concepts, and procedures including FDA 21 CFR 820 regulations, ISO 9001:2015 (E) standard requirements, Clinical Chemistry, ISO13845, ISO1497, 2019 Government of Canada SOR Medical Device Regulations, ISO 11137-1, ISO 11137-2, Directive 2011-65-EC requirements.

Verify receiving inspections rejects involving suppliers’ provided parts and sub-assemblies. Often worked closely with providers on-site along with rework possibilities in order to support production lines timely or rejected the nonconforming products back to the suppliers including the parts didn’t meet child engineering drawing and gage R&R requirements. Communicated with design engineers to resolve engineering print issues that occurred; educated the suppliers on the requirements of the drawing and provided clarification on technical product problems. Trained on and received certification for Material Review Board function. Worked with the suppliers on quality issues for continuous improvements, performed internal/external corrective and preventive actions. Assisted receiving inspection management on clearance of corporate audit findings by communicating with suppliers to provide receiving inspections lost supplier data. Aided Abbott purchasing agent on supplier and procurement quality issues and required quality steps in purchasing operations to ensure that purchased product conforms to specific purchase quality requirements. Supported CAPA management after CAPA provided training by developing process skills and writing SCARs. Communicated with senior supplier quality engineers daily about ongoing quality issues with the suppliers, occasionally travel to the warehouses, five or seven miles away from the main building, in where some of the supplier’s nonconforming large subassemblies segregated, stored and ready for SQE examination and verification to validate the cause of rejection.

Aug 2018 – Sept 2018 Verify, Inc., Irving, TX Quality Engineer

As a Quality Engineer lead a team of Quality Inspectors as well as performed complex First Article Inspections (FAIs) on Boeing 737X, 767, 777, and 787, Lockheed Martin F-35 parts and assemblies and coach suppliers in Brazil, Malaysia, Turkey, Korea and China on all aspects of Aerospace Standard AS9102, ensured that accuracy and completeness of all engineering design requirements records on the AS9102 forms. Confirmed that the First Article Inspection Record (FAIR) is accurate and completed for a part number or assembly, and that all part, product, and characteristic accountability aspects are addressed prior to approval. Assessed supplier performance data and present weekly reports to leadership. With my skills, knowledge and practical experience of the AS9102 standard, provided inspection & preparation all aspects of first article packages in accordance with the standard. With my strong background in manufacturing in the aerospace or military / defense industries and practical experience inspecting aerospace components and assemblies as well as knowledge of applicable industry standards, coached and trained other inspectors.

Feb 2017 – May 2017 Wesco Aircraft/Verify Inc., Northlake, TX Quality Engineer

Support major Quality Assurance CAPA activities involving Wesco Aircraft’s customers and suppliers externally, and internally dealing with Wesco’s systematic problems and the personnel handling the issues. Review customer complaints and reported nonconformance involving their orders placed on Wesco during the month; collect necessary documentations internally and externally, analyze the problems, evaluate the priority of necessary corrective actions, contact involved personnel and put together necessary data and facts in order to respond customer requested corrective and preventive actions effectively and timely. Present detailed CAPA evaluations, findings, and proofs to upper management prior to responding and sending back customer’s forms for approval with the evidences that show effective actions are taken to analyze root causes of problems, corrective and preventive actions are in place.

Sept 2015 – April 2016 Lockheed Martin/Unitek Quality Engineer/Source Inspector/Management

Travel regularly to the supplier site, which is in another state, to perform supplier quality engineering and management, perform final reviews and source inspections of etching, anodizing, filming, priming, electrical bonding, fuel coating, and top white plating operations to support LM Corp F-35 and F-16 products being processed in the manufacturing facility in order to verify finished products meeting the software and hardware testing protocols, Pro-CAD and review of engineering drawings, purchase orders, manufacturing processes including fabrication and welding, clearing gage R&R issues, and quality assurance/control programs' standards and requirements. Identify nonconforming products, segregate and hold them, and make necessary communications and arrangements with supplier's management and production personnel to rework the deficiencies per LM standards. Keep daily log on source inspected, validated, certified, and identify the factors of nonconformance of F-35 and F-16 orders, and report material reviews weekly and inform the upper Quality Management in LM about quality rating of material.

Sept 2007-July 2014 FM Global/FM Approvals, Norwood, MA Quality Engineer/Auditor/Management

Planned and created the Plano office based technical quality audit group first time for FM Approvals covering Southwest states and Mexico. Quality engineered and managed, scheduled any given quality systems audits of suppliers monthly and quarterly, made travel arrangements, traveled and performed Texas, Oklahoma, Louisiana, Mexico, and Arkansas first and surveillance technical quality audits of quality systems of over 300 manufacturing client's manufacturing sites involving electronics, embedded testing including software and hardware requirement, test qualifications, electrical controls, pumps, fire stop material, fire proof wall panels, actuators, metal coating, pipes medical device and assemblies, fabrication/welding, gage R&R validations and corrections, and hazardous material control. Prepared and reported quality audit findings in a soft form to upper management weekly. Witnesses product qualifications at client's manufacturing site, and when required collect samples from manufacturing lines and sent them to main testing laboratory in Canada for recertification. Trained and mentored new coming technical quality auditors including on the job quality audit orientation at the client's site. Arranged Southwest Technical Quality Auditors meetings in Plano office location and assisted on their travel plans, hotel selections, and arranged lunch and dinner social business meetings around the area. Managed material and documentation reviews on non-conformances found during the technical first, surveillance, and follow up quality audits, and reported the findings and closures to upper quality management.

2006-2007 Eaton Corp/LM Aeronautics, Ft. Worth, TX Lead Auditor/Quality Engineer

Provided quality engineering management services of design quality reviews, conducting first article inspections, gage R&R validations, supplier source activities, fabrication and welding, witnessing acceptance tests of hydraulic systems including valves, actuators, reservoirs and accumulators for Lockheed’s F-35 program. A successful first flight of F-35 fighter jet is accomplished. Traveled major Supplier sites and represented Eaton on technical quality issues, determined and maintained Eaton quality standards and procedures for product development and production, embedded testing protocols as well as software and hardware, analyzed complex product failures, provided advice, assisted on supplier variances and solutions. Created an earlier matrix for variant FN inventory, BOM for scheduling and strategic expediting. Researched 1D and 2D bar coding marking requirements, provided a study report to management, and followed with suppliers for compliance.

As Lead Auditor, planned and traveled to Supplier sites and conduct AS 9100 Quality Management System audits on small businesses. Conducted the meetings with supplier’s management and wrote various reports about the audits to Eaton Supplier Management. Trained third party and supplier personnel on Eaton’s source inspection procedures and endorsed DQR compliance. Issued 8D corrective action notifications to the suppliers having repetitive discrepancies, evaluated the CAR’s. Reviewed and analyzed manufacturing process steps and procedures, created VISIO diagrams. Provided liaison activities and interfaces between Eaton and LMA design engineers to work on CAD design issues and related purchase orders with buyers. At the Ft. Worth LMA and Eaton facilities as an only Eaton Quality representative has exercised sound judgment and applied decision-making skills with minimal supervisory intervention. Provided expert source and FAI inspection services for customer’s brackets for F-35 aircraft on behalf of Eaton-Michigan drop shipments those needed customer’s source inspector approvals.

2005-2006 Northrop Grumman Corporation/Aerotek, Garland, TX Quality Engineer

Conducted quality management system audits, lead the audit team in preparation of Northrop’s electro-optical facility for ISO 9001 recertification process with a different registrar. Made written recommendations and advised the upper management about immediate improvements of the facility and the processes, possible remedies, and the elimination of obstacles prior to certification. Created VISIO decision making steps and process flow for major processes. Analyzed DoD and NATO standards and contract requirements, reported to management on compliance deficiencies. Wrote reliability testing procedures based on DoD standards and requirements, entered DoD required testing data in for reporting, and witness tested the major critical processes.

1996-2002 BOEING-Irving Co., Irving, TX Lead Q Auditor/MRB/Global Q Engineer/Management

Developed company’s internal quality audit program from concept to reality. Planned, scheduled, and conducted quality system management audits internally, and acted as internal consultant to guide the company through realization of FAA ACSEP and third-party ISO certification and approvals. Performed Gap Analysis and made recommendations, and company wide system integration. Investigated and pursued courses of managerial and engineering actions necessary to obtain desired results involving new business strategies. Translated contract and regulatory agency requirements into work requirements, processes and tasks. Member of Material Review Board (MRB). Resolved technical problems that would critically affect performance, fabrication and welding, proper usage of gage R&R, quality assurance engineering, cost and schedule. Worked with design engineers’ CAD problems and corrected deficiencies. Reviewed and analyzed major process flows and created the decision-making steps in VISIO. Evaluated product nonconformance, managed corrective actions, and performed root cause analysis. Set up, review and maintained international offset work-in progress for five years to ensure specifications, design, test criteria, and quality requirements are met. Independently performed International assignments in Turkey, Singapore, and Malaysia involving ISO 9001, ISO 9002, D1-9000, and AS 9100 Quality Management System audits on major contract Suppliers without direct supervision. Involved in Program and Budget review meetings and translated through both languages in Turkey. Along with carried executive roles and tasks during the weekdays, on the weekends; entertained co-workers, upper management and their families planning and guiding with many touristic trips during their stay in Turkey.

1995-1996 Hydra-Rig, Inc., Ft. Worth, TX Quality Engineer

Prepared the oil and gas rig company for ISO 9000 qualification, acted as consultant, and developed company’s quality management systems, selected ISO registrar and have obtained ISO 9002 certification for the company. Conducted internal quality system and satellite company audits and assessments. Performed local Supplier audits, corrective actions, and cause analysis. Wrote technical procedures, prepared manuals and data books.

1994-1995 RAYTHEON/Alyeska PS Co., Anchorage, AK QA Lead Auditor/Quality Engineer

Constructed vendor quality assurance program, and the internal/external quality management system audit department from concept to implementation for Alaska pipeline system and its major pump stations. Researched and analyzed material, planned and scheduled and conducted corporate quality assurance and regulatory compliance audits. Evaluated and audit Suppliers quality systems including fabrication and welding, gage R&R, primary contractors, engineering firms, and project partners. Wrote DOD required audit and technical reports, procedures, and work instructions on quality department and created VISIO diagrams for new procedures.

1989-1994 EG&G Science Corp, SSC Lab, Dallas, TX Lead Auditor/Quality Management/Quality Engineer

Held managerial, lead auditing and design quality engineering positions in world’s famous high energy physics DOE project, Superconducting Super Collider (SSC), mainly quality system applications, design engineering of magnets on pro-CAD and facility development, performed new technology design transfers between national laboratories and industries. Developed technical audit program and conducted more than 150 Supplier system audits, surveys, inspections on fabrication and welding, gage R&R, and evaluations including small, minority, and women owned manufacturing and engineering Supplier facilities those providing materials and assemblies for collider accelerator system, R&D labs, dipole and quadruple magnets, cryogenics and large detectors. Developed and performed Supplier quality audit program, also reviewed vendor contracts. Created, implemented, and maintained Approved Supplier List and database. Developed and implemented Supplier corrective action system and lab-wide counterfeit material control.

1988-1989 Gerry BPC, Denver, Colorado Quality Assurance Supervisor/Quality Engineer

Simultaneously held both supervisory and engineering positions in high volume assembly plants, mainly in the quality assurance areas of managing quality assurance and control personnel, and department’s budget, MRB chairing and engineering, vendor control and analysis, supervising remote receiving inspection personnel and facility. Reported quality department activities weekly-monthly-quarterly to upper management. Analyzed customer returns and complaints: resolved the issues. Interfaced with engineering group on design improvements and product safety issues.

1972-1987 Sundstrand Advanced Operations, Denver, CO Quality Engineer, System Planner, MRB, Class A Inspector

High volume precision aerospace company in the activities of quality assurance and control operations for DoD aerospace projects, missile and B1 and B2 programs, NASA Space Shuttle, and commercial airplanes (Boeing, Airbus, MD, Bombardier) high tech materials, components and assemblies. Engineering and inspection experiences were involved in DCAS interface and needed high control of manufacturing lines of lathes, drills, deburrers, precision polishing, broaching, milling, drilling, surface, ID/OD and jig grinding, precision gear manufacturing, internal and external threading, brazing, welding sand blasting, passivation, nitriding, carburizing aerospace part and assembly processes, and 3 & 4 axis CNC machined components. Quality Engineering tasks also involved of employee training on DoD quality requirements, gage R&R, technical and procedure writing including creating VISIO process diagrams, quality manual preparation, quality department administration, First Article Inspection (FAI) and gage planning, calibration programs, report preparation for DoD, cleaning room and final inspection, Member of Material Review Board (MRB), CMM programs validations. Receiving inspection, fabrication inspections for welding, zyglo, magnaflux, NDT, X-ray processes, corrective action programs, configuration control, tool and gage studies, statistical process control (SPC) green or black belt implementation and trend analysis.

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