Jorge L. Porras
Senior Manager Quality Assurance and Compliance @Tosoh Bioscience
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WORK HISTORY
Senior Manager Quality Assurance and Compliance @Tosoh Bioscience
South San Francisco, CA, US
EDUCATION
Universidad Tecnológica del Centro
Chemical Processes
Sonoma State University
BS, Chemistry
SKILLS
ABOUT JORGE L. PORRAS
Senior Medical Device/ Biopharma Quality professional with extensive global experience in Design Control and Manufacturing of Medical Devices, IVDs, CDx, and quality systems development, integration, and validation. Broad progressive management experience leading and establishing Quality Assurance teams for managing and auditing class medical devices, and Biopharma products, QE support for facilities and operations, product design control, non-conformance and CAPA management, change control, and facilities, equipment, process, and product validation. Expert in new product introductions and production support balancing speed to market and regulatory requirements. • Quality Systems implementation for ISO, CFR, MDSAP, IVDR, and MDR compliance • Design Control - Design Verification and Validation• Non-conformance, CAPA, and Customer Feedback Management• Risk Management, and Design Transfer • FDA QSIT, Notified Body, and MDSAP Certification Audits • Quality engineering for Facilities, Equipment, Process, and Test Method Development and Validation• Sterilization and Biocompatibility • Design Dossier, 510(k), IDE Submissions and Technical File
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