2017 -2018 Director of Quality Assurance and Regulatory Affairs (QA and RA) @
2015 -2017 Manager of Quality Assurance and Regulatory Affairs @
2014 -2015 Quality Assurance Systems Manager @ Cohera Medical, Inc.
2012 -2014 Senior Quality Engineer @ Cohera Medical, Inc.
2011 -2012 Senior Quality Assurance Engineer @
2010 -2011 Senior Quality Assurance Analyst @
2008 -2010 Quality Systems Business Analyst @
2007 -2008 Quality Assurance Analyst @
2006 -2006 Quality Assurance Intern @
James Gianoutsos Education
University of Pittsburgh - Joseph M. Katz Graduate School of Business
Indiana University of Pennsylvania
James Gianoutsos Skills
Product Development
cGMP
21 Cfr Part 803
CE marking
Trackwise
Visio
V&V
Manufacturing
SPC
Six Sigma
ISO 14971
Root Cause Analysis
Lean Manufacturing
Medical Devices
FMEA
21 CFR
Verification and Validation V&V
Corrective and Preventive Action Capa
FDA GMP
SAP R/3
Testing
Research
DMAIC
Risk Management
Quality Auditing
Quality Assurance
Arena Simulation Software
Canada Consumer Product Safety Act
GMP
ISO Standards
Process Capability
Quality Systems
MS Office Suite
Arena
Microsoft Office
21 CFR Part 820
Project Management
SAP BW
CAPA
Minitab
Medical Devices Directive Mdd
ISO 13485
Auditing
MS Project
Quality Control
Quality System
FDA
Consumer Product Safety Commission Cpsc
Design Control
Quality Management
Design of Experiments
21 CFR Part 11
ISO
Gage R&r
Supplier Quality
u.s. Food and Drug Administration Fda
u.s. Food and Drug Administration
Corrective and Preventive Action
Verification and Validation
Consumer Product Safety Commission
Medical Devices Directive
James Gianoutsos Summary
James Gianoutsos, based in Pittsburgh, PA, US, is currently a Founder and CEO at Rimsys Regulatory Management Software. James Gianoutsos brings experience from previous roles at Regality Consulting, LLC, Carmell Therapeutics, Circadiance and Cohera Medical, Inc.. James Gianoutsos holds a University of Pittsburgh - Joseph M. Katz Graduate School of Business. With a robust skill set that includes Product Development, cGMP, 21 Cfr Part 803, CE marking, Trackwise and more. James Gianoutsos has 2 emails and 1 mobile phone numbers on RocketReach.
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