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. CompaniesGeneral 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: