Quality Management System Major. ISO 16949, ISO 13485, ISO 11607, EN 13795:2011
2013 3M Automotive Division CTE & I Award for Gen 4 Paint Protection Film.
2013 3M Automotive Division Golden Step Award for 3M Ventureshield Paint Protection
Sr. Product Assurance Engineer December 2014 to Current3M Company Infection Prevention Division － Saint Paul, Minnesota
Led non-conformance investigations to determine root causes and recommend corrective actions regarding component failures, finished goods failures.
Investigated customer complaints, including product / record investigation, health risk assessments, identification of CAPAs, and report generation
Developed verification, validation, and qualification plans and reports
Led Change management audits team to identify gaps, recommend improvements, best practices to make sure compliance with FDA and ISO 13485 requirements..
Developed and maintained strong working relationship with functional
groups (R&D, ME, Quality Operations, Supply Chain and Regulatory).
Coordinated change impact assessment activities.
Employed LSS to lead continuous improvement projects to support enhanced product quality and quality systems.
Led Supply Management: providing technical assistance to suppliers/other
resources performing qualification/validation testing. Assure the
resolution of all issues raised during design development, processing and
Developed a robust risk management evaluation with each supplier regarding
impact of processing and change control.
Led the team to work on multiple projects such as cost saving, process/ product improvement.
Excel at completing projects accurately, on time, and within budget.
Managed and ensured effectiveness of quality systems, manufacturing process, and product testing to mitigate risks and achieve customer requirements.
Led division activity on maintaining ISO TS 13485, ISO 11607 Certification.
Launched new non-woven surgical drapes to regain market shared.
Successful to deliver two cost savings projects, saved 800K / year for division.
Qualified new overwrap by utilized using non-woven material replacing the paper overwrap for all 3M Steri Drape. As the result, saved for division 350K annually.
Qualified new surgical tape which utilized from one of plastic drape waste slugs cutout replacing current tape strips for all 3M Steri Drape. As the result, saved for division 500K annually.
Sr. Quality Engineer August 2010 to November 20143M Automotive － Saint Paul, Minnesota
Qualified second sources extruding manufacturing to improve product quality, and prevent back order.
Developed qualification plan to transferring manufacturing in order to improve quality defect DPPM from 60000 to 6000 saved $500K annually
Developed and commercialized Paint Protection Poly-Urethane Film for 3M Automotive Division.
Employed APQP to launch new products, PPAP Submission follow AIAG requirements.
Interacted directly with OEM's customers to increase customer's satisfactions, reduced complaints, and maintained division DPPMs target.
Participated internal & supplier audits to ensure ongoing compliance to regulatory requirements and design specifications ISO / TS 16949
Established and managed suppliers. Developed product quality plans for outsourced manufacturing to ensure a consistent and stable level of quality.
Led Supply Management. Managed two major suppliers / maintained TQRDC's
Drove PPU and Operational Excellence initiatives within the assigned product families.
Developed warranty management tool and product testing to mitigate risks and achieve customer requirements.
Led Import Export NPI projects Interpret Regulations and Standards to compliance with ISO / TS 16949.
Used ISM, CFR, Qlikview to analyze and drive continuous improvements.
Maintained COPQ for engineering films business closely to identify opportunities for improvements.
Launched new paint protection film to regain market shared.
Qualified second sources coating manufacturing to improve product quality, and prevented back orders.
Developed qualification plan to transferring manufacturing in order to improve quality defect DPPM from 60000 to 6000 saved $500K annually.
Sr. Manufacturing Engineer March 2007 to February 2010Brady Corporation － Brooklyn Park, Minnesota
Challenged with increasing product quality, improving process, and reducing cost while maintaining or improving safety for large thermal transfer ribbon manufacturer.
Developed, evaluated, documented and advance manufacturing methods and processes through Lean techniques and Kaizen Events.
Analyzed and re-engineer production lay outs, designed and implemented efficiency and quality improvement projects across production lines.
Collaborated with administrative and financial teams to establish viable support of consolidate manufacturing location globally.
Provided on going production support and troubleshooting.
Key Results: Collaborated with senior management on manufacturing consolidation efforts.
Transferred slitters from US to Mexico, and over-sea (China, Malaysia), gaining labor saving from 50% to 80% while maintaining productivity and quality.
Collaborated with senior management on manufacturing consolidation efforts Redesigned gravure coater and transfer from Minnesota to Milwaukee, increase 7% productivity and save communication annually while maintaining product safety and quality.
Conducted Lean Event Total Preventive Maintenance, ensuring optimal equipment operation without costly downtime.
Redesigned printer assembly layout, achieving 15% improvement in overall productivity while reducing required manpower by 5%.
Developed accurate operation measurement standards to increase 10% production yield, minimize non-value-added time to increase 20 % productivity, and reduce cost for slitting process to convert both thermal transfer ribbon, and tape.
Saved 750K annually directs labor by transferring 10 slitters from US to Mexico.
Sr. Manufacturing Engineer February 2005 to March 2007Brady Corporation / Global Diecut － Milwaukee, Wisconsin
Monitored and analyzed workflow, procedures, and line activities, identified and resolved bottlenecks to maximize die cut efficiency.
Created die cut cost models to support customer proposals and cost reduction initiatives.
Served on quality assurance team, developing guidelines and procedure to improve standards and performance.
Designed commercialize die cut parts for various market application including: mobile phone, medical, label industrial, and RFID labels by using different die cut methods: rotary (flatbed) die cuts, and rotary laser die cuts.
Developed recommendations, proposals and justifications for new process capabilities and equipment to reduce cost or create additional market differentiation.
Revamped, standardized, and implemented global die cut process to reduce the cost of defected lens from 750K to 150K
Redesigned the die lines of 20 cell phone die cut parts to increase productivity by 15%, gaining more production capacities.
Developed and implemented printing, laminating process for Mini-Razor Motorola phone as result of 900K sale & 300K profit.
Developed recommendations, proposals and justifications to buy new printing - die cut machine Mark Andy 6 colors to expand Brady printing capabilities and productivity.
Worked with Global team to expand die-cut manufacturer to Korea, and China as results die cut manufacturer geographic had been expanded 15% and immediately responded to customer needs with one day die cut sample turn around.
Process Engineer July 2000 to February 2005Brady Coated Product － Milwaukee, Wisconsin
Worked directly with customer to establish process running conditions, specifications for Brady Toll coating business, lead the commercialization processes for new products in compliance with ISO 9001: 2000, GMP, FDA.
Conducted optimization process for multi production coaters.
Developed, scaled up and commercialized Brady medical, pharmaceutical products.
Generated comprehensive protocols for testing/analyzing the product.
Generated design assurance documentation for the project.
Conducted process validation by follow the guidance from FDA and Global Harmonization Task Force.
Identified potential saving, improvement opportunities and solved challenging technical, process-flow and resource-limitation problems.
Worked with customers and project team in developing process running condition to make paint protection of 6.42M sale.
Formally recognized for leadership of basis development and process design for external business toll coating 25M toll coating project.
Saved $125K monthly for polyamide label by redesigned slot die & heat exchanger since 2003.
Bachelor of Science : Chemical EngineerUniversity of Minnesota － Minneapolis, Minnesota, USA