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Quality Engineering

Location:
Irvine, CA
Salary:
100000
Posted:
August 24, 2020

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Resume:

ROBERT K. FUJIMOTO

** *********, ******, ** ***** 949-***-**** ***********@*****.***

QUALITY ENGINEERING

Manufacturing & supplier quality engineer with experience in new product development, sourcing & purchasing, production manufacturing, and after-market (sales) support. Technical skills include:

• Extensive knowledge of the International Organization for Standardization / ISO 9001: 2015 - Quality System Standard, and SA8000 for Regulatory Compliance

• Working knowledge of FDA CFR 21 - Part 820, and ISO 13485 requirements

• Ability to audit, advise, and consult organizations with QE in pursuit of compliance for a diversity of products, processes and standards

• Technical writing skills with the ability to produce manuals, procedures, work instructions and flow-charts for any technical or business application and provide training thereof

• Application experience with Advanced Product Quality Planning (APQP) New Product Introduction (NPI) Production Part Approval Process (PPAP) Process Failure Mode & Effects Analysis (PFMEA) Measurement System Analysis (MSA) Six-Sigma Lean Manufacturing Kaizen Statistical Process Control (SPC) EMPLOYMENT HISTORY

Oakley, Inc. Foothill Ranch, CA

Design driven and leading eyewear manufacturer with annual sales in excess of $3.1B Sr. Quality Manufacturing Engineer July 2016 – June 2020 Lead manufacturing QE responsible for all Oakley and ‘Eyewear Safety System - ESS’ military eyewear which is classified as an “FDA Class 1 Medical Device” resultant of its applied (safety) warfare use with strict optical & performance requirements (i.e., ballistic impact). Supported APQP and PPAP processes for new product releases and applied improvements for existing products. Managed military frame molding using process control plans and run charts including maintenance of technical drawings and SOP’s for finished good assembly & packaging. Act as ‘Lead ISO 9001’ representative’ responsible for:

o Maintenance of all Quality Management System (QMS) documents (i.e., procedures, work instructions & flow-chart) including ‘Oakley’s Quality Manual’ in compliance with ISO 9001:2015 and FDA CFR 21 requirements

o Lead trainer for all QMS documents

o Process owner of internal audits and ‘Corrective Action / Preventive Action’ (CAPA) o Management of Oakley’s military product certification list (including ‘Approved Protective Eyewear List’ - APEL, and FDA Export Certification) Oakley, Inc.: Sr. Supplier Quality Engineer Mar 2002 – July 2016 Lead QE for Oakley’s Apparel, Footwear and Accessory (AFA) products manufactured internationally. Used APQP and PPAP processes for development of new products, supplier development, and product transitions. Provided leadership reports for AFA quality and regulatory compliance, and responsible for QE activities as follows:

o Support for AFA new product development using PFMEA and MSA tools o Supplier ISO 9001 Quality System audits prior to production approval o CAPA process for supplier product and process improvements o Development and implementation of the ‘AFA Responsible Sourcing’ program for supplier regulatory compliance of environmental, health, safety, fire, and labor requirements o Source inspection and reporting activities using SE Asia and Latin American auditors Honeywell Aerospace Systems & Equipment Tucson, AZ Fortune 500 Company and leading manufacturer of aerospace equipment systems with annual sales exceeding $250M

Sr. Supplier Quality Engineer Jan 1998 – Nov 2001 QE for procurement sourcing activities including the establishment of supplier part families and the use of transition strategies in pursuit of site productivity, cost-savings, and supply-base reduction objectives. Managed supplier CAPA process including provision of management reports. Lead supplier technical liaison for hardware and software issues related to the Cabin Pressure and Environmental Control production-lines. Conducted supplier quality system, product & process, and software audits.

o Acquired $2.4M in supplier productivity savings and a 40% supply-base reduction o Transitioned the Electrical Power Generation products from New Jersey to Mexico o Improved supplier CAPA process with a database for improved tracking and reporting o Audited, advised, and certified (6) key suppliers to AS9100 Aerospace Quality Standard, and completed a supplier development project resulting in $50K in savings AlliedSignal / Honeywell Aerospace Equipment Systems Torrance, CA Fortune 500 Company and premier manufacturer of aerospace cabin pressure and environmental control systems with annual sales exceeding $450M

Sr. Quality Engineer / QA Program Manager for Boeing Feb 1990 – Dec 1997 Lead QE responsible for contract review of customer and government requirements ensuring internal flow-down and system compliance for company and suppliers. Provided QE for new product development and production manufacture for a diversity of electro-mechanical assembly products including environmental controls, heat transfer, and mechanical actuators. Assigned as a lead auditor for the initial ISO 9001 certification conducting quality system, supplier, hardware & software audits. Facilitated failure analyses for systemic rejections and functional failures, assisted in the Mexico transition of heat transfer products, and maintained QA site metrics. o Received highest supplier rating from “Boeing Commercial Airplane Group”, and received

“Boeings AWAC’s Blue Ribbon Award” for superior quality & delivery performance o Acquired FAA production OEM approval for the 737 & MD-95 Environmental Control Systems o Acted as “GE Aircraft Engine Division’s Designated Quality Source Representative” responsible for the inspection, acceptance and release of aircraft engine oil coolers o Assigned as “Canadair QA Leader” for quality system compliance for multiple sites o Wrote and received ‘Best-In-Class' for the “George M. Low NASA Quality Achievement Award for all aerospace QA report submittals”

EDUCATION

Masters of Business Administration

Pepperdine University – Malibu, California

Bachelor of Science Degree, Industrial Technology – Quality Engineering California State University of Long Beach, California PROFESSIONAL CERTIFICATIONS

American Society for Quality – Certified Quality Engineer (CQE)

American Society for Quality – Certified Quality Auditor (CQA)

Social Accountability International – SA8000 Certified Auditor

Certified in Lean Manufacturing at the University of Tennessee Lean Enterprise Institute

Certified Green Belt in Six Sigma Tools & Applications at Honeywell Aerospace Division

Certified (Level II) in Supply Chain Methodologies at Honeywell Aerospace Division Note: Professional and Personal References Available Upon Request



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