Quality Engineer /Manager

Donald E. Wrixon

**** ********* ***** ******, ** 92882

951-***-**** (mobile) email: *******@***.***

Employment History

May 2008 – Present QA and Development Manager C.Brewer Company, Anahiem CA

Direct Quality Assurance and Process Development departments for a 30 million dollar medical custom molding facility. Responsible for the managment of the overall quality system including continous improvement and validation processes.

• Led the successful implemetation and certification to TS16949 quality system.

• Improved first pass yields from 92% to 96% by improving defect awareness and implementing improved trending metrics.

• Implemented an enterprize system that integrates automated inspection systems in a single programming and reporting platform. This has improved thoughput through metrology 50%.

• Redesigned the QA laboritories into three separate functional units. This combined with a complete 5S improvement has improved the effeciency and eye appeal of the QA labs.

• The above improvements also allowed for 36% reduction in overtime costs due to improved labor efficiency.

December 2005 – April 2008 Production Manager Cardinal Health, Riverside CA

Manage and operate two manufacturing departments that produce 28 million dollar combined value of production annually: PVPI manufactures iodine solutions for surgical prep. Injection Molding manufactures discrete units used for Airlife, Alaris, Medivac, and Alaris disposables. Responsibilities include maintaining costs within operating budgets; ensuring departmental compliance with FDA, ISO, CFR 211 and GMP requirements. Responsible for directing overall Lean deployment strategy for manufacturing and tracking progress of Lean transformation in Riverside facility.

• Completed Lean Six Sigma Sponsor training April 2006.

• Successully sponsored programs that resulted in over 3 million in savings through inventory reduction, scrap reduction, set-up time improvements and transactional improvements.

• Completed 5S manufacturing floor optimization that resulted in a 60% improvement of set-up times and a 20% improvement of WIP accuracy.

• Reorganized PVPI and Injection Molding supervisors and technical teams to optimize use of in house talent and clarlify accountability. The newly created teams include 2 Black Belts, 2 Green Belts, and 4 Kaisen Leaders.

• These teams demonstrated improved employee engagment through improved overall service levels from 78% to 97%, reduced negative materials variences by $210,00 annually, and identified an additional $120,000 in future opportunities.

May 2005- December 2005 Project/Process Engineer Inland Technologies, Fontana CA

Manage molded plastic product development for medical customers. Develop and validate all manufacturing processes for release to production. Provide technical and engineerinng support to all medical customers.

August 2003–January 2005 Production Manager Hudson RCI, Temecula CA.

Manage and operate three manufacturing departments with a combined operating budget of $1.4 million: Injection Molding, Extrusion, and Auto Assembly departments produce discrete units used in the manufacture of respiratory therapy and anesthesia products. Responsibilities include maintaining costs within operating budgets; ensuring departmental compliance with FDA, ISO and GMP requirements; ensuring that all personnel and productive assets are available to meet forecast and schedule requirements; and developing annual budgets, capital plans and salary plans.

• Improved on-time delivery from 73 percent to 93 percent and cut WIP inventories by $70,000, by reducing machine set-up times and machine downtime caused by chronic machine and process failures and by adjusting staffing schedules to address requirements during periods of peak need.

• Improved shop efficiency 23 percent through implementation of a comprehensive technician improvement program that raised accountability for line output and rewarded efficient line performance.

• Reduced yearly overtime $176,000 due to efficiencies realized by implementing the two programs described above.

• Eliminated $350,000 in yearly negative materials variances by implementing comprehensive scrap reporting, cycle counting, and streamlining materials transactions.

June 1997–June 2003 General Production and Engineering Manager C. Brewer Co. Anaheim CA.

Directed a staff of engineers, supervisors, technicians and foremen for a 24/7 precision custom molding and assembly facility. Responsible for operating to standard costs and for the efficient management of flexible manufacturing resources. Engineering responsibilities included management of key accounts such as Microsoft, Alcon and Alaris Medical and oversight of a team of engineers responsible for process and manufacturing engineering and quality planning.

• Developed and implemented a comprehensive mold qualification procedure that utilized scientific molding practices to optimize the molding process and debug new or transferred tooling. This program is still the focus of a nationwide marketing campaign.

• Organized and led a management team to improve inventory control and product flow through full implementation of current MRP software.

• Developed and implemented plant-wide systems and procedures to comply with new FDA, GMP and ISO 9002 requirements.

February 1993–May 1997 Engineering Manager IMC., Los Angeles, CA.

Led manufacturing engineering team in tooling project management, injection molding process development, and custom manufacturing for a custom molder of thermoplastics materials.

• Traveled abroad (including Taiwan, Japan, Hong Kong, Singapore) to review tool build progress, perform mold sampling and final tool buy-off.

• Organized Design for Manufacturing (DFM) and Design for Assembly (DFA) activities for IMC’s major clients: Hewlett-Packard, Sony, Pioneer, Mitsubishi and Samsung.

• Implemented the use of Pro E software for import and export of customer solid designs and drawings.

• Developed and implemented Gas Assisted Injection Molding (G.A.I.N.) and Controlled Internal Pressure (CINPRES) technologies.

June 1990–October 1992 Process Engineer Spatz Laboratories, Oxnard, CA

Developed set-up parameters for multi-cavity tooling and troubleshot production-related problems for a cosmetics packaging manufacturing firm. Researched, recommended and tested appropriate materials, processes and machinery.

•

Education

Contact this candidate