Advisory Board
Michael
President, GoZucca
Previously as a medical device class II & III corporate executive in Quality, Manufacturing & R&D roles with GE, Johnson & Johnson, Abbott & Phillips. Engineering Degree from Cal Poly Pomona with a Corporate Master Six Sigma from Johnson & Johnson & General Electric. Expert in Enterprise Management, Compliance, Quality Engineering, Supplier Management, DFSS, DMAIC, QMS, GxP, ICH, 21CFR Part 11, 21CFR820, FDA, C/KFDA, PMDA, ISO13485 & 14971,. As a corporate troubleshooter and business transformation executive, Michael has significant experience on multi-billion dollars companies post acquisition and overall sites integration in Asia Pacific, USA and Europe.
Constantine
Program Advisor, GoZucca
Previously as a medical device leader in Quality, Operations and Supply Chain roles with Fortune 100 Companies. MBA and Engineering degree from Purdue University with a Lean Six Sigma Master Black Belt. Expert in enterprise management, compliance & FDA remediation , QMS, ISO 13485 & 14971, Supplier Quality, CAPA, Design Controls, Process/SW Validations, Risk Management, Lean Six Sigma Deployment and Kaizen facilitation. Constantine has been instrumental on influencing key corporate decisions, overall strategy with multi-billion dollars companies, post acquisitions and global quality systems harmonization and integration.
Our People & Experts with over 100 years of medical device experience combined
Michael
QA/Compliance/Design/Operational Excellence
Mulitiinguist
Region: USA, Asia & Europe
Degree: BSc Eng.
Accreditation: Corporate Master Six Sigma (DMAIC, DFSS)
Prev. Companies: General Electric, Johnson & Johnson, Abbott & Phillips Medical
Joe
Medical Device & Life Sciences Regulatory
Multilinguist
Region: USA
Degree: PhD
Accreditation: RAC
Affiliation: AOAC, AAMI & ASTM
Prev. Company: Johnson & Johnson
Rosette
Medical Device & Diagnostic Regulatory
Multilinguist
Region: International
Degree: JD, MBA & MPH
Accreditation: RAC
Prev. Company: Johnson & Johnson
Alfred
Medical & Pharma R&D/NPD
Multilinguist
Region: USA & International
Degree: BSME
Expertise: Drug & Stem Cells Delivery Systems
Prev. Company: Abbott Vascular, Geron &
MAP Pharmaceutical
TBA in Sep
Trademark & Labeling
Multilinguist
Region: USA & International
Degree: TBD
Prev. Company:
TBA in Sep
Project Manager
Multilinguist
Region: USA
Degree: TBD
Prev. Company: