Michael Pon
Quality Management System Leader and Deputy Management Representative at Proteus Digital Health, Inc
Based in Hayward, United States
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Seniority
Manager
Department
Other
Location
Hayward
Industry
Pharmaceutical Manufacturing
Company size
61
Contact information
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m•••••••@proteus.com
Phone
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Background
About Michael Pon
Over 10 years QA, RA, Risk Management, & Validation experience in FDA-regulated industries (Biopharmaceutical, Medical Device, and Combination products) with Management experience to ensure Quality Systems & Compliance programs in conformance to International, Federal, State, & Corporate GxP requirements - Significant accomplishments: • Maintained EU revenue stream of US$140 M • Obtained 4 FDA Market authorizations of IVD systems • Released US$2.5 M of inventory on Quality hold • Secured initial CDPH-FDB licensure & ISO 13485 certification
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