2009 -
2012 Commercial Development Manager, Biomedical Diagnostics Institute @
2005 -
2009 Global Director of Projects @
2004 -
2005 European Director of Quality Assurance and Regulatory Affairs @
2001 -
2004 Business Process and Quality Director @
1996 -
2001 Quality Engineering Manager @
1989 -
1996 Quality and NPI Supervisor @
Fergus Fleming Education
National University of Ireland, Galway
BSc, HDIP in Ed, Dip in QA, Physics, Education, Quality Assurance
1984
-
1989
Fergus Fleming Skills
Sop
Six Sigma
Design for Manufacturing
Biopharmaceuticals
Business Process
SPC
Medical Devices
Molecular Biology
Strategy
Technology Transfer
Commercialization
Research
ISO 14971
Marketing
Quality System
Pharmaceutical Industry
Validation
Manufacturing
Mergers and Acquisitions
Minitab
Root Cause Analysis
Product Development
CAPA
R&d
Chemistry
GLP
Integration
Operations Management
Supply Chain
V&V
Change Management
Mergers
Process Improvement
Lifesciences
Microsoft Excel
ISO 13485
Product Launch
GMP
Quality Management
Lean Manufacturing
Biotechnology
Regulatory Affairs
Continuous Improvement
DMAIC
FDA
21 CFR Part 11
Design Control
Testing
Regulatory Requirements
Biomedical Engineering
FMEA
Design of Experiments
Quality Assurance
Hardware Diagnostics
Fergus Fleming Summary
Fergus Fleming, based in Ireland, is currently a Chief Technology Officer at RenalytixAI. Fergus Fleming brings experience from previous roles at FF Consulting Ltd. Commercialisation Consultancy for Medical Technology Compani, EKF Diagnostics, Abbott and Dublin City University. Fergus Fleming holds a 1984 - 1989 BSc, HDIP in Ed, Dip in QA, Physics, Education, Quality Assurance @ National University of Ireland, Galway. With a robust skill set that includes Sop, Six Sigma, Design for Manufacturing, Biopharmaceuticals, Business Process and more. Fergus Fleming has 3 emails on RocketReach.
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