Experienced Quality Manager with a demonstrated history of working in the electronic, semiconductor and automotive. Skilled in New Product Introductions, Intelligence Analysis, Risk Management, Supplier Development, Cost Savings, Operations Management, and Leadership.

 
 
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LEE YOUNG CONSULTING 2017-PRESENT

Alcon/B Braun Medical Inc.,Carlsbad/Irvine CA

  • FDA remediation expert advising quality engineering function, including activities for process validation (IQ/OQ/PQ), supplier quality equipment qualification and risk management (pFMEA) in HVM IV bag environment (680K/day)

  • Led successful quality operations response to validation related observations found in Warning Letter for a leading pharmaceutical manufacturer.

  • Implemented ISO 13485 compliant design controls for New Product Introduction of Lux Gen 2.0 for Alcon/Tear Film Innovations.

  • FDA remediation work developing and supporting regulatory compliance gaps at suppliers, including supplier Quality Management Systems (QMS) and PPAP activities.

  • Successfully implemented Risk Management Software for Juno Pharma, Medtronic & Sanofi/Genzyme.

 
 

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