Kim Niles

About Kim Niles

At the helm of Quality Enthusiasts, LLC, our team excels in delivering top-tier regulatory, quality, and reliability consulting services. With expertise honed over decades, we specialize in ISO remediation, quality management system development, and statistical problem solving. Our mission is to elevate organizational performance across multiple industries, including medical devices and pharmaceuticals.As a seasoned Professor in Quality Science, the dedication to education is evident. Our influence extends through public speaking and over 44 publications, sharing knowledge that empowers professionals and shapes the future of quality assurance. Our goal is to foster excellence in quality management, ensuring that businesses not only comply with but exceed industry standards.

Experience

1. Founder and President

   Quality Enthusiasts, Llc

   Nov 2018 — Present

   Offering a wide variety of Quality/Regulatory/Reliability consulting and training related services for Johnson and Johnson, Boston Scientific, ThermoFisher and many others.

Education

• California State University-Dominguez Hills

  MSQA, Quality Science

  2000 — 2003

• San Diego State University

  Bachelor of Applied Science - BASc, Engineering/Industrial Management

• San Diego State University

  BSIT, Industrial Engineering & Technology

  1980 — 1984

Skills

• Iso 13485
• Dmaic
• Operational Excellence
• Quality Management
• Statistics
• Leadership
• Doe
• Cqe
• Spc
• Process Engineering
• Research and Development (R&D)
• Root Cause Analysis
• Reliability Engineering
• Continuous Improvement
• Cross-Functional Team Leadership
• Supplier Quality
• Quality System
• Quality Systems
• Validation
• Product Development
• Analysis
• Fmea
• Iso Standards
• Quality Assurance
• Minitab
• Training
• Testing
• Triz
• Thin Films
• Kaizen
• Public Speaking
• Quality Control
• Gmp
• Lean Manufacturing
• Design of Experiments
• Manufacturing
• Supply Chain Management
• Engineering
• Data Analysis
• Six Sigma