Scott Dentino
Chief Operations Officer at Endoluxe
Based in Asbury Park, United States
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Seniority
C-Team
Department
Operations
Location
Asbury Park
Industry
Medical Equipment Manufacturing
Company size
6
Contact information
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s•••••••@endoluxe.com
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Background
About Scott Dentino
Tenacious leader and strategic planner of highly productive LEAN organizations. Implementer of ISO 13485, cGMP and ERP systems. Solid reputation providing transparent leadership. Medical Device Operations / Manufacturing / Quality Assurance Management - Budget and P&L - Integrated Quality Assurance - CFR Title 21 Part 820, cGMP, and ISO 13485 implementation, compliance and certification - Electrical Safety Certification, EN 60601 and EN 62368 - HIPAA Compliance - Process optimization and validation - Equipment IQ/OQ/PQ - Clean room operations - Sterilization processing - Production and Material control, inventory and field inventory management - Outsourced manufacturing, supply chain development and qualification - Forecasting - Warehousing and Distribution - Customer Service Systems integration and IT infrastructure management, ERP system development, implementation, and optimization - Accomplished.NET Developer with expertise in database driven business applications History of hiring and mentoring top performers Experience with the following Medical Device products. Endoscopic visualization equipment, Patient data storage cloud applications, Implantable defibrillators including delivery and extraction tools (catheters), Body surface mapping / Non-intrusive AF trigger mapping diagnostic systems, Drug eluting stent delivery catheters, Endoscopic surgical tools, Cardiac pacing probes and ablation tools, Orthopedic (hip, knee and foot) implants, Pulse Oximetry systems, Drug delivery systems. Technical leadership - Mechanical design - Manufacturing Engineering - Quality Engineering - Usability Engineering - Design for Manufacturability (DFM)- Risk Management (PFMEA)- LEAN/Six Sigma - Supplier development and qualification
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