Industry Knowledge

Product Launch, Product Management, Quality System, Manufacturing Engineering, RF, Verification and Validation (V&V), Testing, FMEA, Program Management, Medical Devices, ISO13485, Corrective and Predictive Analytics

Professional Development

ISO13485 Lead Auditor, High Output Management, Role of the Leader Training, Seven Habits of Effective People TQM Training, FMEA Facilitator Training, Managing Through People, Gartner Global Supply Chain Conference, DOE Training

Areas of Expertise

Six Sigma Black Belt, Continuous Improvement, Productivity Expert, Program Management, Quality Engineering/Operations Expert, Lean Manufacturing, Quality and Engineering Management, Statistical Controls Consultant (JMP& Minitab)

LEE YOUNG

Quality Assurance, Quality Engineering, and Quality Control Consultant for pharmaceutical and medical device companies.

Masters Science (coursework completed), Chemical Engineering

B.S. Chemical Engineering

Associates Arts, Electronics

Selected Highlights

Built high performing teams; quality engineering, manufacturing quality assurance, quality control labs, program management, design controls and validation teams with world-class results.
Grew a team of 18 Quality Engineers to a global team of over 85 within five years at Thermo Fisher Scientific.
Recognized for results driven people management (mentoring, development, coaching), highest employee engagement scores within Operations (11,000+).
Internationally relocated to Copenhagen Denmark to manage quality group for three years.

Experience which includes:

• Quality Engineering; quality operations, continuous improvement.
• Risk Management, Sustainability & Compliance Excellence
• World-class Supplier Management, Manufacturing Operations and Demand / Supply Planning
• Cost and Process Optimization in Product Life Cycle Management
• Skilled in all aspects of GXP. Strong quality professional with proven experience
• Specialized at leading cultural transformation to improve operational excellence