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Steven Downes Location
France
Steven Downes Work
Chief Quality Officer Health and Pharma Solutions @ (May 2025 - Present)
Senior Consultant and Business Coach @ (March 2025 - May 2025)
Independent Consultant | Life Sciences and Quality Leadership @ Freelance (July 2024 - May 2025)
Global Head of Quality Strategy and Business Operations - Vaccines Quality @ (April 2022 - June 2024)
Global Head of Quality and Operational Excellence @ (June 2019 - March 2022)
Vice President Global Head Quality Assurance, Regulatory Affairs and Product Engineering @ (October 2015 - June 2019)
Global Engineering Director - Biopharm and Single Use Systems (Life Sciences) @ (July 2013 - October 2015)
Global Product Engineering Leader @ (January 2011 - June 2013)
Manager, International Disposables Engineering @ (August 2008 - November 2012)
R and D Manager @ (January 2008 - January 2009)
Director - Operations @ Design Packaging Group (October 2006 - October 2008)
Operations Manager @ (January 1998 - January 2006)
Development Engineer @ Biocompatibles (January 1996 - March 1998)
Steven Downes Education
Imperial College London
(Creative Thinking)
2021-2022
University of Wolverhampton
Bachelor of Engineering - BE (Mechanical Engineering)
1989-1993
Steven Downes Skills
Business Development
Business Strategy
Change Management
Combination Products
Communication
Continuous Improvement
Corrective and Preventive Action (CAPA)
Cost Reduction Management
Cross-functional Team Leadership
Cultural Awareness
Danaher Business System
Data Analysis
Device Development
Engineering
Engineering Management
External Audits
FDA GMP
Financial Performance
Good Manufacturing Practice (GMP)
ISO 13485
ISO 14971
ISO Standards
In Vitro Diagnostics (IVD)
Infusion Pumps
Interpersonal Skills
Leadership
Leadership Development
Lean Manufacturing
Life Sciences
Manufacturing
Manufacturing Engineering
Medical Devices
Networking
Observation
Operational Excellence
Operations Management
Pharmaceuticals
Pharmacovigilance
Process Design
Process Engineering
Process Optimization
Product Innovation
Product Life Cycle
Program Management
Quality Assurance
Quality Control
Quality Management
Quality Risk Management
Quality System
Research and Development (R&D)
Risk Management
Six Sigma
Startup Development
Strategic Planning
Strategic Thinking
Supplier Evaluation
Supplier Management
Talent Management
Technical Operations
supply chain
IEC 60601
ISO 17025
3rd Edition
Mechanical Engineering
R&D
Project Management
Directors
International
International Project Management
Manufacturing Operations Management
single use devices
Cultural Transformation
Great Motivator
Customer Experience
Disposables
Plastics Engineering
Electro-mechanical
IV
FDA
Design Control
Biomedical Engineering
CAPA
FMEA
Market Development
V&V
Validation
Capital Equipment
Injection Molding
Design of Experiments
Design for Manufacturing
DMAIC
ISO
GMP
Development
Technology
Cross Functional Team
International Project
Filtration
Cross Functional Team Leadership
Product Launch
Product Development
Electro Mechanical
Cost Reduction
Steven Downes Summary
Steven Downes, based in France, is currently a Chief Quality Officer Health and Pharma Solutions at Roquette. Steven Downes brings experience from previous roles at nextImpact, Freelance, Takeda and Ascensia Diabetes Care. Steven Downes holds a 2021 - 2022 Imperial College London. With a robust skill set that includes Business Development, Business Strategy, Change Management, Combination Products, Communication and more. Steven Downes has 1 emails on RocketReach.
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