CONFIDENTIAL RESUME

PERSONAL INFORMATION

Bruce H. Hiles

**** *, ******** ***.

Sioux Falls, SD. 57106

Phone: 320-***-****

acu2pw@r.postjobfree.com

SUMMARY

Over 39 years of experience in Quality Assurance/Quality Control, with 30+ years in Quality Management. Working knowledge and ability in multiple environments:

Class (7)10,000 and Class (8)100,000 Clean Room Construction, Operation, and Control.

Medical Component and Medical Device Manufacturing, Test and Assembly, Aerospace Supplier Development, Including all aspects of AS9100 and AS9102 documentation. Multi-functional Machine Shops, including Machining Fabrication & Assembly. System development and maintenance for ISO TS 16949, Electronics; Hermetic and Environmental connector manufacture, assembly and sealing. Lab Technology and analysis. Extensive background in Injection Molding for multiple press sizes from small Dyna-cast I ton to 3,300 ton machines.

Injection, multi-nozzle gas assist, gas counter pressure, blow and compression molding

Automation development and implementation

Experienced in the development, implementation and maintenance of Quality Management Systems that have received certification and registration or compliance to the requirements of:

ISO 9001:2008 (and earlier standards)

ISO 13485:2003

AS 9100

ISO TS 16949

cGMP, QSR and associated CFR requirements including 21 CFR part 11

Educational Certifications received for Lead Auditor for ISO 9001:2000 and ISO 13485. Have participated and conducted internal, supplier and third party system and process audits.

Experience with all levels of APQP, PPAP, DOE’s, IP, OP, and QP protocol and performance, Six Sigma, Lean Manufacturing, Process Mapping, Data Collection, Process Capability and Statistical Analysis, report writing and Improvement development and implementation.

EDUCATION

Elementary: Lyman Trumbull, Chicago, IL.

High School: Albert G. Lane Technical, Chicago, IL.

College: Cerritos College, Cerritos, CA.

CERTIFICATIONS & AFFILIATIONS

Certifications:

1980 – Geometrical Dimensioning & Tolerancing (ANSI Y14.5) / Beckwith Institutes

1980 – Shop Math / Beckwith Institutes

1981 – Equivalency Associate of Applied Science – Engineering Technology through Robertshaw Controls Company

1983 – Application in Manufacturing / SME

1985 – Management and Supervision / Beckwith Institutes

1990 – Fundamentals of Injection Molding / Texas Plastics Institute

1994 – ISO 9000 Internal Auditor / UL and RIT

1994 – NAFTA / Global Partners

1995 – Smart Scope Programming / OGP

1995 – World Class Manufacturing / GE Corporation

2001 – ISO 9000:2000 / Excel Partnerships

2005 – Lead Auditor – ISO 9001:2000 / Underwriters Laboratories and Stat-A-Matrix

2005 – Lead Auditor – ISO 13485:2003 / Underwriters Laboratories and Stat-A-Matrix

2006 – Six Sigma training and principles / Plexus Corporation

2006 – Potential Failure Mode Effects and Analysis (FMEA) / Plexus Corporation

2006 – Advanced Product Quality Planning (APQP) / Plexus Corporation

Affiliations:

Senior Member – Society of Manufacturing Engineers (SME)

Senior Member – Society of Plastics Engineers (SPE)

Senior Member – American Society for Quality (ASQ, ASQC)

EMPLOYMENT HISTORY

4/2016 – Present

Verify Inc. (contract position) - Working in Brookings, SD.

Title: Supplier Quality Engineer / on assignment

Short term temporary position, Perform all Supplier on-site audits and Supplier Source Inspections for current Military Porjects.

2012 – 2015

Engineered Polymer Cop. ( Bought by Imperial Plastics, Inc.in late 2015), Mora, MN.

Title: Quality Assurance Manager

Responsibilities: Develop and revise Quality Management System that is registered under ISO 9001:2000 to be compliant to AS9001. Initiate and develop product quality plans and processes in relation to APQP and PPAP procedures. Initiate CAPA’s from customer inquiries, feedback, internal process capabilities and DPPM analysis. Interface with Departmental Managers as necessary to ensure compliance to all applicable company, customer and regulatory agency requirements. Processes include injection molding, structural foam molding, multi-nozzle gas assist/gas counter pressure molding, full secondary capabilities including automated paint line, and custom assembly and packaging.

2011 - 2012

Cambridge Metals and Plastics (CMP), Cambridge, MN.

Title: Senior Quality Engineer

Responsibilities: Develop and maintain specific Customer Quality Requirements and establish a strong Customer relationship while at CMP. Assisted in internal auditing as well as perform Supplier Qualification Audits under ISO 9001:2008. Performed in-house process audits and implemented Quality Verification where necessary. My main Customer’s included Honda, Freeman seating and Cooper Electric. Assigned as the Quality Engineer for all Waterworks Projects – Owned and operated by Rob Bass.

2010 - 2011

Applied Quality Management Systems (AQMS), Brook Park, MN.

Owner - Quality Consultant.

Providing ISO 13485:2003 Certification consulting services and on-site support to Crescent Industries, Inc. and Multiple Medtronic facilities in Minnesota.

Temp positions in the Aerospace and Automotive Industries.

2009 – 2010

Crescent Industries, Inc. / New Freedom, PA.

Title: Quality Assurance Manager

Responsibilities: Update and Revise QMS that is registered under ISO 9001:2000 to be registered under ISO 9001:2008 and ISO 13485 and meets the conformity requirements of cGMP and QSR 820. Establish the protocol for the validation of the Enterprise IQ system for electronic signatures under 21 CFR part 11. Initiate and develop product quality plans and processes in relation to APQP, FMEA’s, Risk Assessments for Medical Device manufacture and DHR content and compilation to meet the FDA QSR 820 requirements. Develop protocols for IQ, OQ and PQ validations. Initiate CAPA’s from customer inquiries, feedback, internal auditing process, product or process capabilities and NPPM analysis. Interface with Departmental Managers as necessary to ensure compliance to all applicable company, customer and regulatory agency requirements. Processes include custom injection molding, mold design and build and Class 10,000 clean room medical device assembly and testing Project coordinator for the design, construction and certification of a 3,000 sqft Class (7) 10,000 Clean Room.

2005-2008

GE Aviation (Formerly: Smiths Aviation / Yakima, WA. and Mukilteo, WA.

Title: Senior Systems Quality Engineer

Responsibilities: Landing Gear Systems, BCMS, BCU, Actuation Systems and Hi-Lift System for the Boeing 787 Dream liner. This included Supplier qualification and surveillance, system reporting, on-site build and test conformance inspection at suppliers and delegated testing facilities, FAA Designee for systems and component conformity – build and test (Statement of Conformity for Aircraft Component Certification 8130-9). Development of Supplier Quality Program (target <50 NPPM), Develop and present status and analysis to monthly PMR (Program Management Review) meeting between GE Aviation and Boeing (BCA) Senior Program management.. Develop and maintain all related company, customer, and FAA and systems documentation.

2003-2005 and limited in 2008

Engineered Polymers Corporation (EPC)/ Mora, MN.

Title: Quality Assurance Manager

Responsibilities: Develop and revise Quality Management System that is registered under ISO 9001:2000 to be compliant to AS9001. Initiate and develop product quality plans and processes in relation to APQP and PPAP procedures. Initiate CAPA’s from customer inquiries, feedback, internal process capabilities and DPPM analysis. Interface with Departmental Managers as necessary to ensure compliance to all applicable company, customer and regulatory agency requirements. Processes include injection molding, structural foam molding, multi-nozzle gas assist/gas counter pressure molding, full secondary capabilities including automated paint line, and custom assembly and packaging.

2000-2003

Trademark Plastics / Rancho Cucamonga, CA.

Title: Quality Assurance Manager

Responsibilities: Managed all aspects of the Quality Assurance and Quality Control Departments. Developed, implemented and maintained the QMS which was registered to ISO 9001:2000 and meet the requirements of AS 9000, ISO 13485 and ISO TS 16949. Developed protocols for the manufacture, test, validation, verification and packaging of product within Class (7)10,000 and Class (80 100,000 Clean room environments. Company Management representative for all Customers; ISO, FAA, FDA and other regulatory agencies. Evaluate manufacturing processes and procedures for capability and conformance. CAPA initiator and effectiveness evaluation.

1995-1999 HiRel Connectors, Inc.

Title: Quality Director

Responsibilities: Managed all aspects of the Quality departments for HiRel Connectors, Baumann Engineering and California Contacts. Baumann Engineering and California Contacts are wholly owned subsidiaries of HiRel Connectors. Quality Systems Certified and compliant to ISO 9001, AS 9100, D1-9000, TS 16494 and QS 9000. California Contacts is a screw machine shop which produces electrical connector and cable contacts from a variety of base metals including stainless steel and beryllium copper. Baumann Engineering is a full machine shop which produces custom and Mil-Spec connector shells and components using NC and CNC lathes, mills, milling centers and metal finishing. Materials included stainless steel, aluminum, titanium and copper. HiRel connectors produces hermetic and environmental custom and Mil-Spec connectors, cables, and electronic assemblies for the automotive, aerospace, medical and defense industries.

1990-1995 and again in a Limited position in 1999 - Microdyne Plastics, Inc. / Ontario, CA.

Title: Quality Manager / Division Manager

Responsibilities: Managed all aspects of the Quality Department. Additional duties included the management of the secondary and assembly operations department which included fixture design, fabrication and assembly. Responsible for the start-up and operation of Microdyne’s Tecate, Mexico facility which included permit and site selection, equipment and fixture installation, utilities contracts, employee recruitment, customs documentation, customer contracts, scheduling and daily operations. In the initial year of start-up the facility grew from a 7,000 sg.ft. / 20 employee operation into a 100,000 sg.ft. facility with 50 employees, 6 injection molding machines, 2 blow molding machines as well as automated and manual assembly/packaging for a variety of products for the medical, automotive, electronic and sports equipment industries.

I returned to Microdyne in 1999 under an agreed 6 month contract, at the request of the company president, to re-implement procedures, policies and operations in the Tecate facility. During the six month contract the facility operations and capacity returned to 87% from the 45% capacity prior to my return.

1981-1990 J.P.W. Industries, Inc. / Anaheim, CA.

Title: Chief Inspector / Quality Manager

Responsibilities: Managed all aspects of the Quality department including the incorporation of NRC and FDA regulations.

1978-1981 Robertshaw Controls, Co. / Anaheim, CA.

Title: Inspector / Cordax Inspector

Responsibilities: Set-up and inspection of machined and molded product. Performed Receiving, First Article, In-Process and Final Inspection/Test. Programmed the Bendix Cordax CMM.

1974-1978 United States Marine Corps (Vietnam Era Veteran)

Rank: LCpl

MOS: Ammunition Technician Specialist / Armory (2311 / 2111)

Professional and Personal references are available upon request.

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