SUMMARY:

• 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: Medical Devices/Bio-Tech, Pharmaceuticals, Aerospace/Defense, Automotive, HVAC Equipment, Petroleum, Petrochemical, & Natural Gas, 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 & 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 are in need of 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.
• Source Inspection/Vendor Surveillance System Audits/Process Validation
• Quality Management, Planning & Analysis Quality Information Systems Development
• Statistical Process Control (SPC) Trainer Military, FDA, OSHA Regulatory & Statutory Laws
• Configuration & Document Control Reliability, Maintainability & Product, & Safety
• Non - Destructive Testing (NDT) Regulatory Affairs Compliance
• Quality Cost Analysis Metrology/Calibration Qualification Protocol
• TQM/J.I.T./Six-Sigma/ISO-9001 Facilitation Design of Experiment (Taguchi Method)
• Supplier Selection, Development & APQP& Variation Management Focus
• Test/Inspection Methods Development Contract/ Bid & Proposal Review
• 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 in order 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, GageTrak, 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 EXPERIENCE:

QA STAFF ENGINEER/SUPPLIER QUALITY MANAGEMENT

Confidential, Fort Worth, Texas

Responsibilities:

• Assigned to the JSF F-35 Program as subject-matter expert for the manufacturing processes for Advanced Product Quality Planning (APQP) & Variation Management.
• 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.
• Assessed quality systems for deficiency identification & correction. Ensured corrective measures met acceptable standards & documentation compliance to requirements.

MANAGER QUALITY & VALIDATION

Confidential, Houston, Texas

Responsibilities:

• 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 s. Utilize advanced Quality methodologies, i.e. 8D, RCA, 5 why’s Affinity Diagrams, six-sigma, etc., & related measurement methods & techniques.
• Develop 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.

QA MANAGER

Confidential

Responsibilities:

• Planning strategic direction for professional 25 person team comprised of QMS auditors, technical inspectors, trainers, customer satisfaction, documentation management & administration. Develop sufficient policies & procedures. Provided direct support of company’s Quality Management System & Directed quality & regulatory activities. Provide management direction for Quality & organization.
• Promotes, teaches & presents quality processes for work improvement & efficiency. Coordinate, monitor & reports on customer comments program. Assure viable & secure documentation management system. Interface with Army Contracting Agency (ACA)Quality Assurance Representatives (QAR).
• Prepared & presented quality s at monthly self-assessment briefing. Oversee the maintenance of technical files IAW EC & ISO requirements. Co-ordinate & liaisons with ISO registrar. Identified potential improvement to current processes using change management principles.
• Establish quality reporting guidelines for identifying adverse quality trends. Provide regulatory & ISO compliance leadership guidance & technical support to Directorates & other departments. Coordinate internal audit program. Plans, coordinates & conducts semi-annual Quality Management Review.

SENIOR SUPPLIER QUALITY/DEVELOPMENT ENGINEER

Confidential, El Segundo, California

Responsibilities:

• Assigned supplier base focal for Supplier Development & Quality 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.

CUSTOMER COMPLIANCE & VALIDATION MANAGER

Confidential

Responsibilities:

• 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

Confidential, Vienna, Virginia

Responsibilities:

• 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 companies.
• 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 the purpose of 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. Provide extensive client support & service to ensure accreditation integrity to the International Quality Standard.

FDA REGULATORY VALIDATION/QUALITY ASSURANCE ENGINEER

Confidential, Temecula, California

Responsibilities:

• Defined product reliability & quality goals IAW FDA & EU State Regulatory/Statutory Requirements & 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 & 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.
• Sustained the electrical data from production sustaining, monitor & troubleshoot yield problems & drove continuous improvements utilizing statistical methods such as SPC/DOE/FMEA to insure product/process/design were robustness. Reviewed protocols and reports & shaped experimental strategies as required.
• Established an effectively relationship with customers and regulatory agencies by interfacing effectively & using advanced engineering measurement techniques to ensure adherence to both customer expectations, existing/new legislation & federal, state, and local legal requirements.
• Established complex and critical specifications by the use of statistical tolerancing, math modeling, and experimental testing results.