About Us




James “Gunny” Shore is the Chief Quality Officer at Quality Lean Solutions, consulting for Medical Device companies helping them improve in Compliance, Quality Systems, Operational and Lean Manufacturing. Jim has 25 years of quality and supplier management experience working in medical devices, semiconductor, aerospace and defense (Titan Medical, Lake Region, Nypro Healthcare, Boston Scientific, Aspect Medical, ACMI, Brooks Automation, and Raytheon). His professional certifications include 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). James is a Certified Welding Inspector and Test Supervisor for the American Welding Society.

James has served the ASQ Society as a Member Leader for over eighteen years; Boston Section Chair, Region Director (New England), Section Affairs Council Vice-Chair, Board of Directors, and Treasurer of the Biomedical Division. Currently, James is the 2019 Chair of the Biomedical Division and Deputy Region Director (New England).

James was a major contributor to the recent Certified Supplier Quality Professional certification. He wrote several chapters for the ASQ Handbook, helped create the training materials and has taught the public prep classes several times.

James is the co-author of the book entitled “Proactive Supplier Quality Management in the Medical Device Industry,” which is published by Quality Press. 100% of the royalties are donated to Veteran service organizations. Jim served in the United States Marine Corps for 15 years and was Honorably Discharged at the rank of Gunnery Sergeant (E-7).


Our Approach

Simple Sustainable Solutions

We work with our customers to understand their needs and requirements, then develop solutions that are simple and scale able.  "One size does not fit all" in this industry nor does it in business, so we customize it so it can be followed if you are five of five hundred person company.


Why Us?

 Our service includes a comprehensive consult to help identify gaps and opportunities, a comprehensive report that includes a project plan with timelines and milestones, a cost analysis, and a schedule. We also offer a suite of quality products that will help you get there quickly and smoothly. That’s how we ensure your success.