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OWNER

LEE YOUNG

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

 

Education

ARIZONA STATE UNIVERSITY, TEMPE, AZ.
Masters Science (coursework completed), Chemical Engineering

UNIVERSITY OF ARIZONA, TUCSON, AZ.
B.S. Chemical Engineering

UNITED AIR FORCE, DENVER,CO.
Associates Arts, Electronics

 
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Break Down

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

Hands on experience maintaining robust compliance posture with respect to 21 CFR 820, ISO 13485:2016, IVD Directive 98/79/EC, IVDR, ISO17025, Canadian MDR, and ISO 14971:2008.

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)

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

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

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.