Commercial Development Manager, Biomedical Diagnostics Institute @ (January 2009 - April 2012)
Global Director of Projects @ (October 2005 - January 2009)
European Director of Quality Assurance and Regulatory Affairs @ (April 2004 - October 2005)
Business Process and Quality Director @ (January 2001 - January 2004)
Quality Engineering Manager @ (January 1996 - February 2001)
Quality and NPI Supervisor @ (January 1989 - January 1996)
Fergus Fleming Education
University of Galway
BSc (HDIP in Ed, Dip in QA, Physics, Education, Quality Assurance)
1984-1989
Fergus Fleming Skills
21 CFR Part 11
Biomedical Engineering
Biopharmaceuticals
Biotechnology
Business Process
CAPA
Chemistry
Commercialization
Continuous Improvement
DMAIC
Design Control
Design for Manufacturing
Design of Experiments
FDA
FMEA
GLP
GMP
Hardware Diagnostics
ISO 13485
ISO 14971
Integration
Lean Manufacturing
Lifesciences
Manufacturing
Marketing
Medical Devices
Mergers
Mergers & Acquisitions
Minitab
Molecular Biology
Operations Management
Pharmaceutical Industry
Process Improvement
Product Development
Product Launch
Quality Assurance
Quality Management
Quality System
R&D
Regulatory Affairs
Regulatory Requirements
Root Cause Analysis
SPC
Six Sigma
Sop
Supply Chain
Technology Transfer
Testing
V&V
Validation
Strategy
Research
Mergers and Acquisitions
Change Management
Mergers
Microsoft Excel
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 in HDIP in Ed, Dip in QA, Physics, Education, Quality Assurance @ University of Galway. With a robust skill set that includes 21 CFR Part 11, Biomedical Engineering, Biopharmaceuticals, Biotechnology, Business Process and more. Fergus Fleming has 3 emails and 1 mobile phone numbers on RocketReach.
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