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Develop World-Class Quality Systems and Metrics: How Structural Changes Can Reduce Cost and Increase Efficiency
James “Gunny” Shore — the Chief Quality Officer at Quality Lean Solutions — literally wrote the book on QMS (Proactive Supplier Quality Management in the Medical Device Industry), and he is here to teach you what you need to create a world-class quality system.
With his “Simple Sustainable Solutions” method, you can evaluate your current QMS, identify the areas that need simplifying, make your QMS easier to follow and help develop a new QMS, if required.
Mr. Shore will also guide you to put in place a metrics-based feedback loop to ensure your quality system is working efficiently — driving the right decisions and behaviors.
Drive the right decisions in your QMS by implementing the “Simple Sustainable Solutions” process. Create a QMS that’s compliant with ISO 13485/MDSAP certification and spur process improvements through lean manufacturing principles.
James “Gunny” Shore is the Chief Quality Officer at Quality Lean Solutions, consulting for medical device companies, helping them improve in compliance, quality systems, operations and lean manufacturing. Mr. Shore has 25 years of quality and supplier management experience working in medical devices and other industries. He is an ASQ-Certified Six Sigma Black Belt, ASQ-Certified Quality Manager/Operations Excellence, Certified Quality Auditor and Certified Mechanical Inspector and ASQ Senior Member (joined in 1988). Mr. Shore has served the ASQ Society as a Member Leader for 18+ years, and is currently the 2019 Chair of the Biomedical Division and Deputy Region Director (New England). He was previously the Boston Section Chair, Region Director (New England), Section Affairs Council Vice-Chair, on the Board of Directors, and Treasurer of the Biomedical Division. He was a major contributor to the recent Certified Supplier Quality Professional certification, wrote several chapters for the ASQ Handbook, helped create the training materials and has taught the public prep classes multiple times. Mr. Shore is the co-author of Proactive Supplier Quality Management in the Medical Device Industry, published by Quality Press, with 100% of the royalties donated to Veteran service organizations. He served in the United States Marine Corps for 15 years and was Honorably Discharged at the rank of Gunnery Sergeant (E-7).
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