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Quality Engineer Clean Room

Location:
Shreveport, LA, 71101
Salary:
75000
Posted:
May 28, 2023

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Resume:

DAVID M. STUCKEY I.E.,

ASQ/CQE/CQA, SME/CMfgE

IRCA Registered ISO 9000 Quality Systems Lead Assessor LM21 Green Belt Certified

Shreveport, Louisiana 71118-4323

Mobile: +1,504-***-****

adxdue@r.postjobfree.com

To Whom It May Concern:

As a Quality Science Industry Leader that Promotes Utilizing Lean Six-Sigma Concepts and Methodologies in Achieving Process Excellence, I have recently been pursuing both Locally & Nationally; the Top-Manufacturing Companies that are Recognized Leaders in the Manufacturing & Servicing of: Aerospace/Defense, Medical Devices/Bio-Tech, Pharmaceuticals Automotive, HVAC Equipment, Oil, Gas & Energy, Consumer Products, Electro-Mechanical Industry & Advanced Composites Fabrication. I am seeking a position where my Over 30 Years of Extensive Experience in the field of Quality, Reliability, Manufacturing, and Industrial Engineering; & Supplier Management would be fully utilized. As such, I would like very much, to explore the possibility of joining a well-respected organization such as yours; one which consistently demonstrates its Commitment to Excellence, Strongly Supports Quality Tools & Methodologies including Advanced Quality Planning (APQP), Total Quality Management (TQM), Lean Six Sigma, Continuous Quality Improvement, International Quality Management Systems Standards, e.g. ISO 9001, ISO13485, FDA Part 820 QSR (Class I, API Spec Q1 & TS) & Consistently Exceeds Customer Expectations & Satisfaction! In reviewing the enclosed resume, please find, I offer a comprehensive background & extensive experience in a multitude of manufacturing discipline encompassing a mélange of electronic/electromechanical products & technologies including (but not limited to): Electronics/Electro-Servo Mechanical/SMT CCA Assembly, Wire-Harness Assembly, PWB Fabrication, Discreet Electronic Component Fabrication, Electronic Sub-Assembly and Systems Level, e.g., (Mainframe/Major-Top-Assembly), Qualification/Acceptance Functional Validation Testing, Sheet Metal Fabrication, Precision Machining, Special Processes, i.e., Chemical Milling, Welding, Heat Treating, etc. & Advanced Composites. I feel well qualified to provide & contribute to your organization; the catalyst needed for strong & effective Quality-Driven- Leadership, Value-Added Guidance, Strong Quality Improvement, Promoting and Supporting a Philosophy of Teamwork, and Championing Company Culture with a Goal for Customer Satisfaction! If you need a person with such skills, I would appreciate very much, the opportunity of a personal interview at your earliest convenience to discuss in greater detail, how my background & experience might be mutually beneficial. Thank you for your consideration. Please contact me at the above address, or by telephone. I look forward to hearing from you. Sincerely,

DAVID M. STUCKEY, I.E.,

ASQ/CQE/CQA, SME/CMfgE

IRCA (UK) Registered ISO 9000 Quality Systems Lead Assessor LM21 Green Belt Certified

Enclosure: Resume

DAVID M. STUCKEY I.E.,

ASQ/CQE/CQA, SME/CMfgE

IRCA Registered ISO 9000 Quality Systems Lead Assessor LM21 Green Belt Certified

Shreveport, Louisiana 71118-4323

Mobile: +1,504-***-****

adxdue@r.postjobfree.com

OBJECTIVE

Utilization of over 30 years’ professional quality/manufacturing engineering & management experience to provide quality leadership in support of a Company committed to Customer Satisfaction, dedicated to the Concepts & Methodologies of Total Quality Management, Just-In Time, & World Class Manufacturing & Six Sigma / Lean Manufacturing, DMAIC solution process! SUMMARY OF EDUCATION & EXPERIENCE

• Source Inspection/Vendor Surveillance • QMS, EH&S Audits/Product/Process Validation

• Quality Management, Planning & Analysis • Quality Information Systems Development

• Statistical Process Control (SPC) Trainer • Regulatory & Statutory Laws, i.e. FDA, DoD, CGMP

• Configuration & Document Control • Reliability, Maintainability & Product, & Safety

• Non-Destructive Testing (NDT) • Regulatory Affairs Compliance – 501 (k), US/EU

• Quality Cost Analysis • Metrology/Calibration Qualification Protocol

• ISO/Six-Sigma/EH&S, MSA Facilitation • Design of Experiment (Taguchi Method)

• Supplier Selection, Development & Certification • APQP/PPAP, CAPA& Variation Management

• Test/Inspection Methods Development • Contract/ Bid & Proposal Review INTERPERSONAL / TECHNICAL SKILLS

Ability to utilize sound judgment of priorities; Effective oral & written communication. Customer/Supplier diplomacy & good will.

Detail oriented organized & disciplined in structural corporate standard operating practices. Excellent retention of data, facts, figures, problems etc. Team player with strong capability of leading & influencing others to reach agreement & understanding of logical conclusions. Ability to evaluate & determine appropriate product quality level, i.e.: sampling plan that maximizes inspection efficiencies. Working knowledge of Military, Federal/Industrial specification & standards including FDA cGMP's. Comprehensive knowledge of manufacturing / quality operations & process including electronic assembly, machined parts, sheet metal fabrication, printed circuit boards, plating & painting, castings & composites. Hands-on utilization of computers including MS Word, Excel, PowerPoint, Access, Schedule, Mail, in addition to Minitab, SAS, SAP, Power Suite, for monitoring, analyzing & reporting quality trends. Ability to review & recommend purchases, i.e.: (capital equipment) in accordance with evolving technology consistent with process, product quality system requirements & providing input relative to preparation of budget. PROFESSIONAL AFFILIATIONS

SENIOR MEMBER: American Society for Quality • Society of Mfg. Engineer’s • Institute for Industrial Engineers SECURITY CLEARANCE: Secret Level: Issued by Defense Investigation Service (DIS) 1990 & 2003 SCHOLASTIC AWARDS: National University Scholarship Recipient • Dean’s List: 1981 – 1990 Page 2

ACHIEVEMENTS

Developed experiments by applying factorial & other techniques as appropriate for solving complex products & processes problems.

Established & implemented quality programs in compliance with ANSI/ASQ. International Quality Standard including ISO 9001, AS9100C, ISO/TS 16949, ISO14001/BS7750, FDA Quality System Regulations Title 21 CFR Part 820 (formerly cGMP's), ISO 13485:2003, CE Marking, ISO12001-1, MIL-Q-9858A, MIL-1-45208A, Boeing 131-9000, Rev. A, FAR Part 21, ANSI ZIA, ANSI/NCSL Z540-1 (formerly MIL-STD-45662A), ISO 10012, NASA 5300, IPC-A-610B, ANSI/J- STD-0001, SMT, LCD Clean room, IPC Specifications, AS9102, AS9103, API Spec-Q1, AIAG/IAQG-APQP & PPAP. Implemented a successful Total Quality Management Program & Statistical Process Control system. Obtained Defense Electronics Supply Center (D.E.S.C.) Laboratory suitability approval for large facility testing IAW MIL- P55110.

Developed & conducted employee training & certification programs for Advanced Composites Fabrication, ANSI Y14.5M- 1994 - Dimensioning & Tolerancing, Statistical Process Control (SPC) & soldering workmanship Requirements IAW MIL- STD-2000A.

Developed company quality assurance manual IAW ISO 9001:2008, ISO 13485:2003, FDA Quality System Regulations Title 21 CFR Part 820, MIL-I-45208A & MIL-Q-5858A, Technical Procedures & Instructions. Established audit inspection & acceptance test for Work in Progress resulting in significant reduction in appraisal quality costs.

Developed SOP’s qualification protocol reports and applicable Laboratory Personal. Developed quality improvement program including implementation of Robust Design of Experiment Techniques. Implementation of Process Capability Studies, Control Charts, Quality Trend Data & Quality Metrics to measure improvements.

Implemented Quality Function Deployment (QFD) programs for assuring product compliance with customer requirements. Successfully cut quality costs by incorporating a Quality Improvement Program (QIP) as Quality Assurance Manager for a Military Electronics Hardware Defense Contractor; Responsible for a staff of 30-35 employee's including Quality Engineering, Test, Metrology, Supplier Control, Reliability & Inspection. As the QA Manager, I reported directly to the Company’s President & C.E.O.

CERTIFICATIONS

ASQ Certified Quality Engineer (CQE) • ASQ Certified Quality Auditor (CQA) • S.M.E. Certified Manufacturing Engineer

(CMfgE) • SPC Instructor • NDE/NDT • Design of Experiment • Quality Circles Trainer • Total Quality Management Facilitator • Aircraft Structures & Advanced Composite Fabrication • Electrical Communication • Quality Function Deployment (QFD) • Just-In-Time (J.I.T.) Manufacturing • Houston International Safety Training Institute (OSHA Accredited) • National Leadership Award • ANSI Y14.5 • Geometrical Dimensioning & Tolerancing • Failure Modes & Affects Analysis (FMEA) • RAB/IRCA ISO 9001, ISO13485, AS9100 Lead Auditor Training - QMI Ltd. • RAB/ IRCA Registered Lead Auditor • Certified LM21 Green-Belt - Lockheed Martin • Lean Enterprise Champion Training • ISO 13485, AS9100, ISO/TS 16949 Certification Training • API SPEC Q1 & Internal Auditor Training. • OHSAS 18001 Training & Certification • Laboratory & Clean Room Personal Safety Training • IPC-A-610 • ANSI Welding Code D1.1. EDUCATION

MASTER OF SCIENCE: University of Southern California: Major: Systems Management, Institute of Safety & Systems Management, Los Angeles, California, & Emphasis: Organizational/ Management: 1992. BACHELOR OF SCIENCE: Southern Illinois University, School of Engineering & Technology: Major: Industrial Engineering, Emphasis: Manufacturing Operations, Minor: Applied Statistics. Carbondale, IL. 1990. ASSOCIATE OF SCIENCE: San Diego Mesa College: Major: Quality Assurance Technology; San Diego, California 1987. Emphasis: Management & Technology.

Page 3

WORK HISTORY

QUALITY MANAGEMENT SYSTEMS CONSULTANT: (Process Improvement Projects Independent Contractor): As a Self-Employed Quality Management Systems Consultant, the past 3 years, I have provided serviced to a multitude of Clients, Industries including (but not limited to) Aerospace, Automotive, Medical Devices, Petroleum, etc. 2014 to Present:

As Process Improvement Project Leader & Quality Management Consultant, clients where offered a total business solution integrating problem solving relative to process, people, & technology. Process improvement required the redesign, survey, research quality tools & techniques, i.e. Six Sigma, APQP/PPAP & statistical analysis (SPC), etc. Strongly & clearly communicated was essential to maintain strong client relationships resulted in clients receiving cost reductions, maximized systems, & overall company enhancement & effectiveness. In addition, it required the ability to work collaboratively with a consulting team & with client. Customer & Government Agencies Specific Regulatory & Statutory requirements.

As an Independent-Contractor required has a multitude of experience, skills & knowledge as to each industry’s unique & yet similar Quality Requirements. The various positions & duties also required the ability to think analytically & translate it into client education. Strong expertise in Quality Management Systems, i.e.: ISO 9001, ISO 13465, AS9100, TS16949, FDA QSR, 21 CFR Part 820, API Spec Q1, ISO14001 & OHSAS 18001 was imperative. QA STAFF ENGINEER: (SUPPLIER QUALITY MANAGEMENT): (APQP & VARIATION MANAGEMENT TEAM LEAD) - Lockheed Martin Aeronautics, Fort Worth, Texas: 2010 to 2014. Lockheed Martin is an American global aerospace, defense, security, and advanced Technology Company with worldwide interests:

Assigned to the JSF F-35 Program as subject-matter expert for the manufacturing processes for Advanced Product Quality Planning (APQP) & Variation Management. Assessed quality systems for deficiency identification & correction. Ensured corrective measures met acceptable standards & documentation compliance to requirements. Coordinated with Engineering to develop & implement process audit criteria & surveillance requirements for both hardware & assemblies within the Lockheed Martin supply chain. Developed, modified, applied & maintained quality evaluation & control systems & protocols for processing materials into partially finished or finished materials product. Collaborated with engineering & manufacturing functions to ensure quality standards were in place. Designed & analyzed inspection & testing processes, mechanisms & equipment; conducted quality assurance tests; & performed statistical analysis to assess the cost of & determine the responsibility for, products or materials that did not meet required standards & specifications. SENIOR QUALITY ENGINEER: (SYSTEMS & VALIDATION): Suntron Corporation, Houston, Texas: 2007 to 2010. An electronic contract manufacturer providing support of complex products within the Aerospace

& Defense, Industrial, Semiconductor Capital Equipment, Network & Telecommunications, & BIO- Medical Equipment market segments:

Working with customers, program managers, & engineering staff to develop techniques & procedures for inspecting & testing company product. Identify & develop new q quality metrics as needs arise. Team played with program managers, & engineering staff to define how the quality system will meet the customer’s requirements. Management Representative for AS9100, ISO9001, ISO13485 & FDA GMP Quality Management Systems Certifications. Utilize advanced Quality methodologies, i.e. 8D, RCA, 5 why’s Affinity Diagrams, six-sigma, etc., & related measurement methods & techniques including statistical data analysis methodology to control & improve the design, product realization (manufacturing) & supply chain related processes. Interface with supply chain processes & supplier quality management programs for government & prime contractors purchasing, contracting & subcontracting. Negotiate & document agreements related to supplier quality requirements. Develop, implement, & managing/leading an effective MRB (material review board) program. Lead effective continuous improvement program related to both products & processes. SENIOR QUALITY ENGINEER: (SUPPLIER & DEVELOPMENT): Boeing Satellite Systems, El Segundo, California; 2002 to 2006. Products: Commercial & Military Satellites, System Instrumentation Integration & Major Sub-Assemblies:

Assigned supplier base focal for Supplier Development & Quality of APQP/PPAP activities. Tasks included: maintaining metrics for monitoring performance of assigned suppliers which included moderate domestic & international travel. Worked closely with suppliers & internal customers, i.e., Purchasing, Engineering, Production, etc. to improve Supplier performance via Six Sigma/Lean Manufacturing/Supplier Development tools & practices. Investigated & identified root cause of various systemic quality problems resulting in the implementation of associated corrective actions. Dispositioned & approval anomalies (nonconformance’s) & was responsible for the flow down of quality requirements to the suppliers via PO screening Q-Clauses & IWA process. Developed & maintained internal processes, systems & database. Page 4

WORK HISTORY(CONT.)

CUSTOMER QUALITY ENGINEER: (COMPLIANCE & VALIDATION): Advanced Input Devices (Medical Devices): 1999 to 2002. Coeur d' Alene, Idaho; Products: Manufacturer of Custom Control Panels, Keyboards & Input Devices:

Responsible included developing, building & maintaining the QMS system improvement, GMP & regulatory compliance policies

& processes proactively accompany-wide ensuring adoption of best manufacturing practices across the business. Maintained an overview of the global regulatory environment to ensure Company was positioned to comply through use of the QMS, building relationships throughout enterprise to share key learning’s & deploy changes & improvements, experience in a leadership role within Quality Assurance.

Strong knowledge of quality systems (ISO, GMP, FDA & other key global regulatory bodies), process orientation along with knowledge of Quality Systems Operations & FDA expectations of GMP compliance processes, excellent analytical skills, effective prioritization & problem-solving skills & demonstrated ability to execute & achieved desired results. GLOBAL QMS AUDITING CLIENT MANAGER: British Standards Institute - Vienna, Virginia, 1995 to 1999. Products: Full-Service Quality Management, Training & Solutions Company: Lead Auditor capacity managed ISO-9001/AS-9100/ISO-13485/ISO/TS-16949 Quality Management System on Global Scale. Main SIC Codes included (but not limited to), Aerospace, Electro-Tech, Automotive and Medical Device Manufacturing Firms. As a full time, quality system accredited third party staff registered lead assessor. This position entailed extensive travel of USA, Canada, South America & Europe for conducting, managing & supervising 3rd party quality system audits of Aerospace, Medical Device, Electro-Tech, Automotive, Paper Mill/Lumber & Pulp Processing manufacturers to ensure company compliance of International Quality Standards, i.e.: ISO 9001, AS9100, ISO 13485/EN46001, QS-9000, MIL-Q-9858A, FDA QSR 21 CFR Part 820/CE Marking, & ISO 14001/ BS 7750. Responsible for coordinating the Implementation of ISO 9001 & ISO 13485. Responsible for providing various manufacturing & service-oriented companies, informational presentations of ISO quality system requirements to provide them better insight & understanding of the Quality Standard. Provided extensive client support & service to ensure certification accreditation integrity to the International Quality Standard & adherence to customers’ existing/new legislation & federal, state, and local legal requirements. Reviewed protocols and reports & shaped experimental strategies & established complex and critical specifications using statistical tolerancing, math modeling, and experimental testing results including establishing an effectively relationship with customers and regulatory agencies by interfacing effectively & using advanced engineering measurement techniques FDA REGULATORY VALIDATION & QUALITY ENGINEER: Devices for Vascular Intervention (Eli Lilly), Temecula, California 1988 to 1995. Products: End Vascular Solutions (ES) & development of catheter & devices:

Defined product reliability & quality goals & established the RMA procedures, customer quality reports, CAR, etc. Established procedures for dissemination of reliability information relating to both customers & suppliers & was responsible for implementation & certification of CE/ISO 9001. Defined &, in conjunction with the manufacturing & engineering teams. Developed enabling methods in Quality & Reliability to improve characterization & drive continuous improvement including knowledge of current customer trends in Quality & Reliability requirements & balance those trends against internal time to volume manufacturing requirements. Implemented methodologies, vendor strategies & cost reduction activities. QUALITY CONTROL LABORATORY TECHNICIAN: Calbiochem Pharmaceutical

(Merck): San Diego, California; 1982 to 1988. This position responsible for providing internal customers with technical expertise while maintaining the highest quality services possible. Responsibilities included: Handling Liquid Nitrogen (LN2) utilizing personal protective equipment and good safety practices. Performing Calibration and Validation/Verification of Preventative Maintenance (PM) equipment & performed Environmental Monitoring which included Surface Testing, Air Testing, Media Fills in addition to Maintaining Inspections,

& Testing for proper equipment operation.

Provided administrative support: copying, filing, and archiving records & maintaining Quality Records, forms, & service requests as needed & & assisted Quality Control Senior Technician and Supervisors as needed. Performed Quality Measurements/Assessments necessary to maintain Regulatory Compliance including the Validation of Processing & Testing Methodologies. I also participated in Proficiency Testing as required & assisted Supervision with Writing & Revising SOP’s. Provided Assistance in External/Internal Audit Preparations as directed Personal references & salary history available upon request



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