SUMMARY:

• My current employment objective is to be a Director of Quality Assurance, Product Development or Program Development, Supplier Sourcing and Regulatory Affairs in one automotive, aerospace or medical device company, where I can apply my practical “hands on” administrative, technical knowledge and leadership skills to create, enhance, improve and apply my 35+ years in quality for the betterment of our client companies.
• No one individual can successfully change the culture, overcome internal resistance and implement a “process system”, without the aggregate “team member” culture - a cross-functional team, following a corporate vision can transform an organization, rapidly and permanently.
• For over twenty-four years, I have prepared various companies for certification for the previous and current ISO 90, AS9100:2016D, IATF16949:2016, IS0 13485:2016, ISO 140, ISO 17025 standards, with over 570 successful Initial and Surveillance 3rd Party Registrar audits.
• I have possessed and demonstrated the ability to build entire business and quality management systems, environmental management systems and laboratory management systems that are able to be ISO 3rd Party Registrar certified, where no system had initially existed. CAD-fluent
• In the role of either a Chief Executive Officer or a Chief Operating Officer, this candidate has the capability of establishing a business plan, defining a business model, building a new business or overhauling an existing one, from concept to a profitable venture, for an aerospace, automotive, medical device or commercial organization.
• As a Director of Quality, Regulatory Affairs / Compliance, Quality Systems, Senior Director of Quality & Supply Chain Management, or Internal Auditor, this candidate has demonstrated a track record in the ability to bring an anemic or an undefined quality organization to a “world class” internal and external quality systems-driven entity.
• As a Director of Program Management and New Product Development, this candidate can transform a customer’s ambiguous and undefined product program into a mature and defined product design and development effort, featuring a product development sequence that is one which is designed, tested, technically-specified, manufactured, assembled, packaged, distributed and a customer-service supported program. CAD-fluent.
• This candidate wants to make a difference, in a company that has found itself, in need of transformation, either due to a needed change in leadership, a closed corporation stockholders’ need for profitability or a transition from being a small entity to one that requires external oversight.
• As it relates to business development, this candidate espouses the need for clearly defined process systems that a management team can define, establish and implement a “business system”, with a consistent “business model” - in order for an organization to be successful, it has to define its overall strategy and the tactics that need to be implemented, in support of the overall business objectives.
• Regarding the need to define or completely generate any aspect of the company’s quality system, it is also a process event, with quality-based objectives, where the term “quality” is defined as the reduction in variability of any process event.

PROFESSIONAL EXPERIENCE:

Confidential, Diamond Bar, CA

Program Manager

Responsibilities:

• Train and consult client companies to be certified in ISO-based quality management system, energy management system and laboratory management system standards.

Confidential, Las Vegas, NV

Chief Product Development & Designer

Responsibilities:

• This unit features explosion and access-resistant technologies to prevent the unit's breach.
• Designed and developed the following product lines
• Both the SB-01 and the SB-10 product programs are currently being solicited for state, university and Federal government inquiries, for the protection of "intellectual property", at both the private and government entities.
• Responsible for the establishment and implementation of the IS0 9001:2015-based process manual and job-specific work instructions, Lean Manufacturing, establishment of PPK-U/PPK-L/CPU/ CPL, process planning, internal audits and product regulatory standards.
• Assured quality products and processes by establishing and enforcing quality standards; testing materials and product.
• Maintained quality assurance staff by recruiting, selecting, orienting, training, coaching, counseling, monitoring, appraising and disciplining employees.
• Prepared company-wide financial objectives by preparing the annual and quarterly budget, reviewed expenditures, analyzed variances, then initiated both corrective and preventive actions, which led to Process Improvement.
• Established quality and reliability standards by studying product and consumer requirements with other members of management and with production operators, technicians, and engineers.
• Maintained a high level of product quality (25 PPM) by enforcing quality assurance policies and procedures and regulatory / government requirements.
• Established raw material standards by overseeing manufacturing and engineering requirements; conferring and negotiating with suppliers; devising testing methods and procedures.
• Determined MRB internal and supplier rework standards through inspection and physical testing methods.
• Defined in-process product inspection standards by studying manufacturing methods.
• Developed acceptance standards, methods and procedures for the disposition of completed product.
• Devised test methods and related Job-Specific Work Instructions (SOP-JSWI’s).
• Developed a product quality documentation system by writing and updating quality assurance procedures.
• Prepared product and process quality reports by collecting, analyzing, and summarizing information and trends.
• Established APQP and MRET teams to develop new product, engineering designs and manufacturing process methods.
• Reason for Leaving: Underfunded company necessitating changes to its business plan and requiring financial and manpower changes.

Confidential, Las Vegas, NV

Interim Chief Executive Officer

Responsibilities:

• Responsible for the creation, maintenance and expansion of the Business Model and the, advance planning, provisional staff development, sector business modelling product and business sector planning, long-term budget planning, future product planning, Three-Year Business and Resource Plan, EBITDA reporting, authored the Strategic Plan for Succession and future corporate compliance issues and investor inquiries.
• Responsible for the allocation of external material and manufacturing resources, product process, planning, budget P/L reporting, day-to-day operations, the introduction, orientation and implementation of an effective manual MRP system, the design and implementation of the manpower and materials Scheduling and Forecasting model and a CWS-BWS Off-Standard analysis method for evaluating efficiency of all direct and indirect departments, contracting and hiring of all employees, brought into the company, (b) EBIT reporting, (c) developing and maintenance of the departmental budgets, (d) regulatory affairs assessment for CE Marking Selecting, Risk Management of corporate business and product liability; customer liaison and, controlling all suppliers for the programs listed below.
• Hired and developed five workers for the assembly operations and ten contract personnel for the company’s operations.
• Quality Assurance and Regulatory Affairs Director - Responsible for the ISO compliant quality management system, as well as the transition for certification to ISO 9001:2015 (September, 2015) quality management system, Lean Manufacturing, critical characteristic PPK-U/PPK-L/CPU/CPL definition, Six-Sigma process capability, benchmark analysis.
• Continuously assessed the company’s existing QA and compliance processes.
• Worked in conjunction with all internal company and external customers, appropriate government and supplier liaisons.
• Developed and propagated gap analyses, which focused on actions needed to provide baseline QA programs consistent with customer and supplier expectations.
• Identified key quality assurance parameters applicable to the on-going internal audit of the company Quality Assurance program, which the framework for effective communications with customers and the supplier base, regarding quality audits and their outcomes.
• Directed and benchmarked internal and ongoing compliance with accreditation of ISO-based standards.
• Further defined and maintained quality measurement compliance parameters, by developing quali-metrics for internal customers and suppliers. developed an internal reporting and broadcast structure for all Quality Assurance initiatives develop specific reporting parameters for each direct and indirect department. established and published a base-line knowledge of all key components of the company’s Performance Improvement and Quality Assurance (PIQA) programs. demonstrated highly effective communications skills. encouraged strong management organizational and project management skills proven ability to meet deadlines.

Product Development Director / Chief Product Designer

Confidential

Responsibilities:

• Designed and product developed all VCFD product platforms, which included prototype manufacturing supplier sources development, establishing monitoring and control processes, to V-1 production volumes for the following projects:
• Hired and developed five workers for the assembly operations and ten contract personnel for the company’s operations.

Confidential, Las Vegas, NV

Director of Quality Assurance & Compliance

Responsibilities:

• Responsible for all current and future product planning, investor inquiries, conceptual design allocation of external material and manufacturing resources, product process planning, critical characteristic PPK-U/PPK-L/CPU/ CPL definition, capability, correlation co-efficient studies, GR & R studies, Lean Manufacturing, Six-Sigma process systems, benchmark analysis, generation and maintenance of the company quality assurance manual and customer liaison.
• Developed and maintained a comprehensive quality assurance and compliance Quality Assurance Program, which assessed the company’s existing QA and compliance processes, worked in conjunction with all internal company and external customers, appropriate government and suppliersDefined and executed gap analyses, which focused on actions needed to provide baseline QA programs consistent with customer and supplier expectations.
• Identified key quality assurance parameters applicable to the design, build, and maintenance of the company’s Quality Assurance program.
• Provided for direct and effective communications with customers and the supplier base, regarding quality audits and their outcomes.
• Built internal and ongoing compliance with ISO-based accreditation standards for the company and its supplier base, through the definition and maintenance of quality measurement compliance parameters, by developing quali-metrics for internal customers and suppliers.
• Developed an internal reporting and broadcast structure for all Quality Assurance initiatives, detailing specific reporting parameters for each direct and indirect department - established and published a base-line knowledge of all key components of the company’s Performance Improvement and Quality Assurance (PIQA) programs.
• I have demonstrated highly effective communications skills, encouraged strong management organizational and project management skills; and, have a track record of proven ability to meet deadlines.