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 - December 2004)
Quality Engineering Manager @ (January 1996 - February 2001)
Quality and NPI Supervisor @ (January 1989 - December 1996)
Senior Project Manager, Biomarkers @ (July 2013 - October 2018)
Commercial Development Manager, Biomedical Diagnostics Institute @ (January 2009 - April 2012)
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, Abbott and Trinity Biotech. 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 and 1 mobile phone numbers on RocketReach.
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