Full Resume of Michael Joseph Hahka (U.S. Citizen)

**** ******** ****** ******* ** 92335 Telephone: 909-***-**** / 909-***-**** E-Mail: adl83t@r.postjobfree.com

EMPLOYMENT AND WORK EXPERIENCE SUMMARY

To Whom It May Concern:

As a self-directed project management professional, with excellent team coordination and problem-solving skills, I critically evaluate, discuss with multi-disciplinary working groups the specifics; and, make clear decisions, in unison with executive management for cost and timing options, anticipation of multiple presentations, which would include granular presentations and problem-solving skills.

I have demonstrated the ability to plan, before execution, with over 35 years of “hands-on” and administrative Medical Device, Automotive, Aerospace / Defense and CE Marking (Technical Files, 501(k) experience, etc.) experience, for Quality Assurance, Regulatory Affairs, Project / Product Management, Manufacturing and Supplier Development and Control, and Design, I believe that I could make a contribution to your company, as a medical device quality manager or project / program manager.

Please see this attached resume’ and the Summary Details for each employment.

If there are any questions, please advise, at 909-***-****

Best regards,

Michael Hahka

ISO Associates 07-11-16 to Present

9491 Foothill Boulevard, Suite C319, Rancho Cucamonga, CA 91730

516 N. Diamond Bar Boulevard, Diamond Bar, CA 91765

General Manager - Train and consult client companies to be certified in ISO-based quality manage-ment systems, energy management system and laboratory management system standards, such as ISO 9001:2015, IATF 16949:2016, SAE AS9100:2016D, ISO 14001-2015, ISO 17025:2015, ISO 27001:2017, ISO 13485:2016, ISO 14971:2019, SAE AS9145-2016 (DVP&R, PPAP and APQP).

-Developed, trained and implemented the ISO Associates “COVID-19 Coronavirus Relief Package” and the aerospace contractor sustainability requirements.

-Established quality goals for all products and adjust processes, as required, which highlighted the development of CWS-BWS (Current Work Standards – Budget Work Standards).

- Evaluated actual results and goals, to properly adjust the manufacturing processes.

-Integrated and aligned the manufacturing processes that best achieve qualitative results.

-Worked in a multi-disciplinary groups, which combined a team approach with analytics, requiring management and key stakeholder consensus participation.

-Effectively interfaced with senior management and key stakeholders regarding business planning, current and future work scope, key player buy-in, defined deliverables, current work status and management issues.

-Developed, trained and implemented the DFSS (Design for Six-Sigma) evaluation for all client companies.

-Used RingCentral as the collaborative video-meeting system

Reason for Leaving - Desired manufacturing quality employment and change of responsibilities to one company.

IT StrongBoxx, Inc. / Vehicle CFD Corp 05-05-14 to 07-05-16

855 East Twain Avenue, Suite 123 400, Las Vegas, NV 89189

4224 West Charleston Boulevard, Suite 110, Las Vegas, NV 89102

Program Manager – Managed and developed the QVI blood filtration systems, which included responsibilities, ranging from marketing, product planning, risk management, IVD regulatory requirements CFR / GMP / ISO 13485 systems development, NPI (New Product Introduction), multiple projects management. 21 CFR Subpart E - Cardiovascular Surgical Devices § 870.4260 Cardiopul-monary bypass arterial line blood filter and 30 CFR § 57.5047 - Gamma Radiation Surveys.

-Completed collaborative offsite video conference collaboration efforts, through the use of RingCentral.

-Designed product through CAD Programs – AutoCad 3D, BobCAD, SolidWorks and Pro-Engineer (Raster / Vector Programs)

Director of Quality & Supplier Chain Management Development – 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 analysis.

-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.

-Developed Warehouse Supplier Quality Plan and executed total warehouse control, for all products entering or leaving the company.

-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 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; and, devising testing methods and procedures.

-Analyzed and 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 establishing, writing and updating plant quality assurance procedures.

-Prepared product and process quality reports by collecting, analyzing, and summarizing information and trends.

-Established Advanced Product Quality Planning (APQP) and Material; Review and Efficiency (MRET) teams to develop new product, engineering designs and manufacturing process methods.

-Established the company Supplier Quality Development and the External Audit programs.

-Employed Design for 6 Sigma (DFSS) statistical evaluations for critical part and product characteristics

Quality Assurance and Regulatory Affairs Director - Responsible for the ISO 9001-2008

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 and benchmark analysis.

-Continuously assessed the company’s existing QA and compliance processes, related to lean

manufacturing and Corrective and Preventive Actions (CAPA).

-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, using 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.

-Responsible for the administration of warehouse operations, under the format of supplier develop-ment.

-Built and administrated the receiving and delivery quality systems development and supplier administration of over 200 suppliers and 13 customers.

-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

- Developed 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.

General Manager - 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.

-Contracted and hired all salaried and hourly employees, brought into the company.

- Evaluated and analyzed: (a) EBIT reporting, (b) development and maintenance of the departmental

budgets, (c) regulatory affairs assessment for CE Marking Selecting, (d) Risk Management of

corporate business and product liability.

-Provided customer liaison.

-Administrated and controlled all suppliers for their parts programs.

-Created, expanded and maintained the (a) Three-Year Business and Resource Plan, (b) the Quarterly Business Model, (c) Corporate Infrastructure Advance Planning (CAIP), (d) provisional staff development, (e) sector business modelling, (f) product and business sector planning, (g) long-term budget planning, (h) future product planning, (i) EBITDA reporting.

-Authored the Strategic Plan for Succession.

-Addressed all current and future corporate compliance issues and investor inquiries.

Product Development Director / Chief Product Designer - Designed and CAD product developed, through the use of AutoCad 3D, BobCAD, SolidWorks and Pro-Engineer (Raster / Vector Programs), all Vehicle Computational Fluid Dynamic (VCFD) product platforms, which included (a) prototype manufacturing supplier sources development, (b) establishment of monitoring and control of processes, from Concept design to V-1 production volumes for the following projects:

VCFD 140*****-*** Static CFD Plate - This is a 144" Long, 96" Wide by 58" High gantry plate assembly that is used to evaluate vehicle stability at as many as one hundred position points, which are evaluated for both high positive (+0.8 to +1.00) and / or high negative (-0.6 to -1.00) paired correlations between pairings of those "x", "y" and "z" point sets.

This CFD (Computational Fluid Dynamics i.e. Simulation Engineering) Plate is designed to both verify and validate sets of "paired" contact points, comparing the simulation of the vehicle, with established test changes, for front wheel and rear wheel (a) caster, (b) camber, (c) toe-in, as well as the pre-planned radial changes in the steering wheel 80 .

VCFD 140*****-*** Build Plate - This is a 144" Long, 96" Wide by 58" High gantry plate assembly

that is used to precisely set prototype "x" body sections, for either new or continuous product

development of chassis design parameters, by setting to as many as one hundred position points,

which are able to be targeted "x", "y" and "z" point sets - similar to the VCFD 140*****-*** CFD

Plate, but without the use of correlational analysis.

NOTE: The VCFD 140*****-*** Build Plate is designed to facilitate the physical build-out of both production and racing applications.

VCFD 140*****-*** Dynamic CFD Plate - This is a 200" Long, 96" Wide by 62" High plate

assembly that is used to precisely evaluate load rates of as many as one hundred "x", "y" and "z" point sets, in a "wind tunnel" and wheel roller settings, with a surface articulation of 0 to a maximum of 31-1/2, in order to simulate all of the major test and racing tracks, for new race or production vehicle development evaluate vehicle stability at as many as one hundred position

points, which are evaluated for both high positive (+0.8 to +1.00) and / or high negative (-0.6 to -1.00) paired correlations between pairings of those "x", "y" and "z" point sets.

VCFD 140*****-*** Measurement Plate - This is a 144" Long, 96" Wide by 65" High plate

assembly that is used to precisely CMM measure (Either configured with or without a Direct

Computer Control operational system) entire automotive and truck bodies and chassis or military ground support vehicles.

With this unit, the nearest competitor was offering a CMM machine with this "measurement cube",

at, literally, three times the cost.

VCFD 140*****-*** Light-Duty 5-Axis Machine Pattern Jig - This is a 144" Long, 96" Wide

by 65" High plate assembly that is used to precisely mill machine "negative impression" body patterns, for quick and precise composite body mock-ups for both the automotive racing and prototype "primary surface" body development for the major automotive manufacturing companies.

NOTE: The VCFD product developments were intended for both the automotive and defense system applications.

Chief Product Development & Designer for the following IT Hardware projects, utilizing CAD and external design resources, with Gantt Chart Project Management to all stakeholders:

ITHS Model 100-1 StrongBoxx Project File NC 09-14-09 - This is an eight-blade server

protector “catacomb” unit that is sold through IT Hardware Systems, Inc. to various security

companies; and, to company and security level-approved application sites.

This unit features explosion and access-resistant technologies to prevent the unit's breach.

Designed and developed the following product lines:

SB-01 This was a one-blade server protection unit that was sold and distributed which featured explosion and access-resistant technologies to prevent the unit's breach, by

unauthorized agents.

SB-10 – This is a ten-blade server protection unit that features highly breach-resistant monocoque construction, featuring carbon-filament Kevlar™, armor plate, hydrogel and 736 Superalloy, air dessicant / temperature-controlled interior server environment, along with a proprietary ID access combination of RFI / Face-Recognition / Finger Identification and Final Key-Pad construction, will be catalogued and sold through the GSA; and, has applications for NATO, DoD and other U.S. government services applications.

Both the SB-01 and the SB-10 product programs, with Gantt Chart Project Management were solicited for state, university and Federal government inquiries, for the protection of "intellectual property", at both the private and government entities.

Designed and developed an IVD product that met the requirements of Section 40 CFR § 60.5411a – Degassing Systems and Reciprocating Compressors.

Supervised 15 direct-reports in two facilities.

Used Gantt Chart and the Zoom videoconferencing was used as the collaborative tool.

Reason for Leaving: Two underfunded companies merged, which necessitated changes to its business plan and required financial and manpower changes.

Magic-Skive Corporation 03-05-12 to 05-02-14

2510 East Sunset Road, Suite 5-25, Las Vegas, NV 89120

Program Manager – Managed and developed the expanded Teflon® seal systems, which included responsibilities, ranging from marketing, product planning, risk management / regulatory with Gantt Chart Project Management included requirements CFR / GMP / ISO 13485 systems development, NPI (New Product Introduction), multiple projects management and V1 production volumes. 30 CFR § 250.734 - Subsea BOP system and 30 CFR § 250.739 - BOP Maintenance and Inspection Require-ments and 46 CFR § 142.240 Seal Systems. Designed through CAD Programs – AutoCad 3D, BobCAD, SolidWorks and Pro-Engineer (Raster / Vector Programs).

Required collaborative effort between outside support contractors, through the use of “GoTo Meeting”.

Director of Quality Assurance & Compliance - Responsible for (a) all current and future product planning, (b) applied program management technical services investor inquiries, (c) development of manufacturing and major process development systems, (d) engineered conceptual design and (e) the subsequent allocation of external material and manufacturing resources.

- Promoted continuous improvement processes including (a) product process planning, (b) critical characteristic PPK-U/PPK-L/CPU/ CPL Six Sigma Design for 6Ő, capability, (c) Least Mean Squared correlation co-efficient studies, (d) GR & R studies, (e) KPI’s, (f) Lean Manufacturing, (f) Six-Sigma process systems and (g) benchmark analysis.

- Generation and maintained the company quality assurance manual.

- Provided customer liaison.

- Administrated warehouse operations consisted of the design and administration of products being shipped into and leaving the two corporate warehouses.

- Developed and maintained a comprehensive quality assurance and compliance Quality Assurance Program, which (a) assessed the company’s existing QA and compliance processes; and, (b) worked in conjunction with all internal company and external customers, appropriate government and suppliers.

- Defined 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.

-Developed 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, utilizing highly effective communications skills.

-Encouraged strong management organizational and project management skills.

-Produced a track record of proven ability to meet deadlines.

Interim Chief Operating Officer responsibilities included (a) overseeing the “day-to-day” operations, (b) CWS-BWS Off-Standard Analyses, (c) risk management of corporate business and product liability.

-Responsible for the creation, maintenance and expansion of (a) the ITHS Business Model, (b) corporate advance planning and budget planning, (c) EBITA generation reports.

-Reporting to the ownership for (a) sector business modeling (b) future staff development planning.

Chief Product Development & Designer Designed through CAD Programs – AutoCad 3D, BobCAD, SolidWorks and Pro-Engineer (Raster / Vector Programs), employing Gantt Chart Project Management, for the following projects, utilizing CAD and sub-contracted personnel.

-M130mm "Magic-Skive" 4 -Angle – Release date was 12-05-14 - Machine featured an integrated electric PTO (Power Takeoff Unit), which had the ability to cut Teflon™ sheet material to be 4 skive-cut, at widths of 130mm (5.118") and thicknesses up to 7.95mm (.313").

This tool allows for the fabrication of irregular gaskets, seals and isolation pads for the aerospace, petroleum, medical device and commercial applications.

-M130mm "Magic-Skive" Multi-Angle" - Release Date was April 20, 2015 for global sales and distribution.

With an integrated electric PTO (Power Takeoff Unit), this machine had the ability to cut sheet Teflon™, rubber, polyurethane, and other synthetic rubber sheet materials, as well as round and rectangular gasket and seals at 4 to 39 and at widths of 130mm (5.118") and thicknesses of 9.52mm (.375").

This tool allowed for irregular gaskets, seals and isolation pads to be fabricated for the aerospace, petroleum and commercial applications.

Supervised 20 Exempt and 20 Non-Exempt employees.

Reason for Leaving: Company was underfunded – No New Investors.

IT Hardware Systems, Inc. 07-09-07 to 03-02-12

1155 East Twain Avenue, Las Vegas, NV

Program Manager – Designed through CAD Programs – AutoCad 3D, BobCAD, SolidWorks and Pro-Engineer (Raster / Vector Programs), managed and developed the expanded gamma ray shield system, requiring responsibilities, ranging from (a) marketing, (b) risk management, (c) product planning, (d) regulatory requirements CFR / GMP / ISO 13485 systems development, (e) NPI (New Product Introduction), (f) multiple projects management to initial product development volumes. Product required National Council on Radiation Protection and Measurements (NCRP 2004) - Ionizing Radiation - designed through CAD Programs – AutoCad 3D, BobCAD, SolidWorks and Pro-Engineer (Raster / Vector Programs)

Quality Operations & Regulatory Affairs Director - Responsible for the ISO 9001-2008 compliant quality management system, as well as the transition for certification to the new and to the future ISO 9001 ten Sub-Clause quality management system, product process planning, CE Marking and the CEN/CENELEC Guide 6 Guidelines, as well as all warehouse operations, with over fifty suppliers and twelve customers.

-Responsible for all (a) current and future product planning, (b) investor inquiries, (c) conceptual design allocation of external material and manufacturing resources, (d) product process planning,

-Defined critical characteristics for 2.0 PPK-U/PPK-L/CPU/CPL (Six-Sigma Design for 6Ő Statistical Methodology)

-Directed Good Manufacturing Practices (GMP) applications, which provided (a) process risk management, (b) benchmark analysis and (c) customer liaison, for the aerospace, automotive and commercial projects.

Supervised twenty-five hourly and salary personnel, over a five-year period.

Reason for Employment Change – IT Hardware Systems, Inc. and the Magic-Skive Corporation merged the direct manufacturing and indirect support units.

FASTRAX International / ISO Associates March, 1988 to July 2007

2935 East Chino Avenue, Suite E-5 30, Chino Hills, CA 91709

Program Manager – Consultant – Technical Trainer - Built an $ 18-1/2M, three office, 123-employee business, from an initial $ 335.00 of total investment capital.

Over 500+ successful client initial and surveillance audits.

Responsible for the coordination of subcontractors, direct technical training, business consulting and individual certification preparation for client manufacturing and service companies for international certification to SAE AS9100:2000, ISO 9001:2000, ISO/TS 16949:2000, ISO / IEC 17025:2005, ISO 14001:1996, VAII SQR-004 Dataset et al.

Reason for Leaving - Desired manufacturing quality employment and change of responsibilities.

EDUCATIONAL BACKGROUND

Oakland University (University Drive, Rochester, MI) B.A. Psychology & Statistics

Graduated Magna Cum Laude

Chrysler Institute (Lawrence Street, Centerline, MI) Technical and Management Course Studies

General Motors Truck & Bus (E. South Boulevard, Pontiac, MI) Technical and Management Course Studies

Perry Johnson, Inc. (Sepulveda Boulevard, El Segundo, CA) ISO 9000 Lead Auditor Certification

With QS-9000 Overview

UAW 653 Journeyman Training and Completion - 3022 Class A Inspection

Tool Jig & Fixture

APPLIED SPECIALTIES

Torque Angle Transduction (Window Regulators)

Large Measurement Cube DCC-CMM 3D Coordinate Measurement

Systems

Inert Gas Mass Spectrometry (Chrysler Gasoline Tanks – French Road

Warranty Returns)

Air Filtration Dessicant Systems

36-foot 2-D Straightness Gages

If there are any questions, please advise. 909-***-****

Michael J. Hahka 909-***-****

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