Raul Soto

About Raul Soto

Seasoned professional with a career spanning 30 years in medical devices, biologics…

Experience

1. Senior Principal Software Quality Engineer at Johnson & Johnson Vision Care

   Johnson & Johnson

   Apr 2013 — Present

   Accomplishments: o Guided validation & quality aspects of multiple major international expansions of JJVC\'s SAP Fusion ERP System in AsiaPac, Europe, S. America, Middle East o Led validation efforts for implementation of new multi-site LIMS & MES o Pioneered CSV Remediation project for 30+ fully automated manufacturing lines at the J&J Jacksonville FL site, including HMI/SCADA systems, associated machine vision systems o Established framework for remediation of FDA483 observations at J&J Vision Surgical site in Hangzhou, China, related to Computerized Systems Validation, software quality, Data Integrity, 21CFR11 Technical leadership and Project management: o Lead dynamic team supporting global & local computerized systems projects: manufacturing automation, IT applications, analytical lab instruments, ML-based automated inspection system. o Develop short/long-term strategic visions; align projects, procedures, practices, deliverables, work priorities, bandwidth management. Cultivate robust relationships between team & clients Technical Expertise & Compliance Oversight: o Software quality SQE within JJVC, ensure compliance, validation & defensibility of GxP computerized systems Conflict Resolution & Crisis Management: o Mediator & “firefighter” adept at resolving critical issues, leading groups of professionals & contractors through high-stress emergencies; maintaining a data-driven approach and unwavering integrity. Consistently keep multiple projects with aggressive timelines on track. Industrial Statistics Expertise & Knowledge Sharing: o Guest speaker at both US and international conferences, addressing topics such as validation, data integrity, design of experiments, hypothesis testing, ANOVA, linear and logistic regression, measurement systems capability, statistical process control (SPC), process capability, acceptance sampling, and others. o Designed and delivered a comprehensive CQE Statistics course for J&J Vision in Florida.

Skills

• Machine Vision
• Design Control
• Quality Center
• Biotechnology
• Gage R&R
• Biomedical Engineering
• Sampling
• Minitab
• Process Engineering
• Tissue Engineering
• Iso 13485
• Quality Control
• Validation
• Process Capability
• Design of Experiments
• Medical Devices
• Cell Biology
• Spc
• Test Management
• Gamp
• Gcp
• Change Control
• Software Documentation
• Automation
• Bioinformatics
• V&V
• Testing
• Fda
• Computer System Validation
• Quality Assurance
• Gxp
• Quality Engineering
• Mes
• X-Ray Crystallography
• Spectrophotometry
• Biopharmaceuticals
• Glp
• Quality System
• Sop
• Capa