David Smithstein

About David Smithstein

As CEO of Total Lean Management (TLM), I help companies simplify compliance, improve…

Experience

1. CEO

   Total Lean Management Tlm Qms Software

   Jan 2001 — Present · US

   In my role as CEO of Total Lean Management, I lead the development, growth, and strategic direction of our QMS software platform - delivering world-class functionality at a price point accessible to smaller manufacturers and other regulated companies. I oversee all facets of product innovation, team leadership, and client success, ensuring TLM continues to set the standard for intuitive, AI-powered compliance solutions.Key Responsibilities:Main App Primary Developer – Lead architect and developer for TLM’s core application, driving continual innovation and functionality.Web App Development Project Management – Oversee feature design, usability, and integration to ensure a seamless user experience.Oversee Marketing and Sales Team Activities – Directs strategy, campaigns, and client engagement to drive adoption and growth.Oversee the Support Team – Ensure high client satisfaction and efficient resolution of technical and service inquiries.Oversee Account Representatives – Guide customer relationship management and account retention efforts.Lead Management Review Meetings – Facilitate ongoing evaluation of organizational performance and strategic objectives.Review Internal Audits – Maintain compliance, integrity, and drive continuous improvement across company operations.Under my leadership, TLM has evolved into a trusted partner for quality and compliance teams worldwide — providing powerful, affordable tools that make ISO and FDA compliance easier, faster, and more effective.

Education

• California State University-Long Beach

  Bachelor

  1984 — 1988

• California State University, Long Beach

  Bachelor of Science - BS

  1984 — 1988

Skills

• Quality Assurance
• Process Engineering
• Manufacturing
• Six Sigma
• Quality Auditing
• Quality Control
• Business Process
• Software Development
• Medical Devices
• Saas
• Iso 13485
• Iso 9000
• Management Consulting
• Team Building
• Project Planning
• Lean Manufacturing
• Business Development
• Fmea
• Change Management
• Erp
• Continuous Improvement
• Cross-Functional Team Leadership
• Iso
• Business Process Improvement
• Fda
• Software Project Management
• Quality System
• Program Management
• Process Improvement
• Quality Management
• Spc
• Root Cause Analysis
• Competitive Analysis
• Start-Ups
• Dmaic
• Operational Excellence
• Enterprise Software
• Validation
• Product Management
• Business Strategy