David H. Bush
Director of Quality and Lean @Trelleborg Sealing Solutions
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WORK HISTORY
Director of Quality and Lean @Trelleborg Sealing Solutions
Minneapolis, MN, US
Lead worldwide Quality team to meet customers\' exacting requirements in automotive, medical device, water, and aerospace markets, assuring compliance to IATF 16949, ISO 13485, FDA 21 CFR 820, ISO 9001, and AS9120 requirements.Direct quality systems, audits, complaints and CAPA, data management, product introduction and execution (APQP, FMEA, control plans, validation, PPAP), supplier quality, and customer satisfaction.Support redesign of performance excellence approach and systems and lead Lean problem solving, variability reduction, transactional process improvement, and manufacturing flow improvement, through strategy, daily management, kaizen event leadership and facilitation, and training.
EDUCATION
University of Minnesota
Bachelor's Degree, Mechanical Engingeering
University of Minnesota
Master's Degree, Industrial Engineering
University of Minnesota
PhD, Industrial Engineering
SKILLS
ABOUT DAVID H. BUSH
I am a hands-on and strategic leader, creating top-line value through product and customer relationship excellence, and bottom-line value by optimizing processes and developing talent for unsurpassed performance.Success in medical device, clinical, aerospace, and other critical applications.Selected Year/Year Improvements 50+% in customer product quality for two consecutive years by developing and leading comprehensive 5S, mistake-proofing, and lean process flow improvements 12% in lean manufacturing maturity 21% in transactional/knowledge work value-stream throughput and 10% in quality metrics by creating visual execution systems Core CompetenciesLEAN MANAGEMENT - Led Lean strategy and process management, manufacturing, transactional, and knowledge work.PROJECT MANAGEMENT - Led or coached up to 13 concurrent teams in design, manufacturing, and administration, created custom project management training, and trained at multiple U.S. sites.SUPPLIER QUALITY MANAGEMENT - Audited and collaborated with suppliers in Mexico, Belgium, Malaysia, Singapore, Taiwan, Philippines, China (Guangzhou, Shenzhen, Tianjin), Canada, and throughout the U.S.QUALITY SYSTEMS - Developed and led user-focused systems for:• Product design, including failure modes and effects analysis (FMEA), design review, CE marking, RoHS, REACH, and Conflict Minerals• Manufacturing, including production qualification and mistake-proofing• Process, system, and product audits and regulatory compliance for ISO 9001, ISO 14001, FDA QSR 21 CFR 820, ISO 13485, IATF 16949• Customer quality, including change management, CAPA, surveillance, and data analytics STATISTICAL ANALYSIS - Improved products, yields, and decision making with design of experiments (DOE), Weibull reliability analysis, factor analysis for assessment validation, and statistical process control (SPC).PROBLEM SOLVING - Led and trained root-cause corrective & preventive action, creative problem solving, and TRIZ methods.
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