Ramon Ricart
Proactive Quality, Regulatory and Technical Operations Executive Bringing Life Sciences to Life and Profitability
- Role
- Vice President Global Technical Operations, Heart Valve Therapy at Edwards Lifesciences Llc
- Location
- Irvine, CA, US
- LinkedIn followers
- 500 followers
About Ramon Ricart
Senior quality, regulatory and technical operations executive with demonstrated team…
Experience
Vice President Global Technical Operations, Heart Valve Therapy
Jan 2016 — Present · Irvine, CA, US
EDWARDS LIFESCIENCES, Irvine, CA 2016 – PresentVP Global Technical Operations – Heart Valve NetworkResponsible leader for the Technical Heart Valve Network [California, Singapore & Costa Rica] functions associated with New Product Introductions, Advance / New Materials & Molding Selection, Process Development, Validations, Technical Training and Valve Manufacturing Automation.•Developed, led and implemented the design, scale up and manufacturing for the first Dry Heart Valve Process delivering an incremental revenue of $100MM.•Led and implemented cell approach to reduce validation execution time by 40%.•Developed the 5 years Vision, Strategy and Roadmap for the Global Technical Operations to achieve status of Center of Excellence for Innovation / improvement for Validation, Technical Training, Automation and Talent Development for succession planning.
Skills
- Cross-Functional Team Leadership
- Iso 14971
- Root Cause Analysis
- Regulatory Affairs
- Quality Control
- Gmp
- 21 Cfr Part 11
- Ce Marking
- Research and Development (R&D)
- Iso 13485
- Design of Experiments
- Manufacturing
- Quality System
- V&V
- Management
- Fmea
- Fda Gmp
- Cqe
- Product Development
- Technology Transfer
- Dmaic
- Regulatory Submissions
- Leadership
- Biomedical Engineering
- Statistical Process Control (Spc)
- Change Control
- Iso
- Pharmaceutical Industry
- Business Process Improvement
- Fda
- Standard Operating Procedure (Sop)
- Continuous Improvement
- 21 Cfr
- Good Laboratory Practice (Glp)
- Design Control
- Medical Device Directive
- Cqa
- Quality Management
- Lean Manufacturing
- Validation
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