Rafael Montelongo

About Rafael Montelongo

Dynamic medical devices industry expert with more than a decade of specialized experience in risk management, data analytics, and quality assurance. Proven track record of training and leading teams to drive organizational improvements through meticulous risk management strategies and data-driven decision-making. My professional journey is defined by a relentless pursuit of process enhancement, strategic alignment of Quality and Regulatory Compliance, and fostering collaborative relationships with Post-Market, Quality, Regulatory, Clinical and R&D sectors. Eager to engage with healthcare professionals and advance the growth and success of forward-thinking organizations.

Experience

1. Quality Assurance Engineer

   Integralife

   Aug 2024 — Present · US

   Spearhead the assessment and implementation of design changes across various product lines, ensuring compliance with scheduled timelines and Quality Management System (QMS) standards.Responsible for maintaining risk management files and completing patient safety risk assessments, health impact assessments and updates to the RMF triggered by nonconformances at the site level.

Education

• The University of Texas-Pan American

  BS, Mechanical Engineering

  1992 — 1998

Skills

• Capa
• Engineering Management
• Program Management
• Iso
• Business Process Improvement
• Fda
• Process Engineering
• Continuous Improvement
• Six Sigma
• Quality System
• Lean Manufacturing
• Process Simulation
• Testing
• Kaizen
• Statistical Process Control (Spc)
• Engineering
• Risk Management
• Root Cause Analysis
• Published Author
• Failure Analysis
• R&D
• Quality Control
• Fmea
• Pcb Design
• Corrective and Preventive Action (Capa)
• Spc
• 5s
• Design of Experiments
• Manufacturing
• Cross-Functional Team Leadership
• Smt
• Failure Mode and Effects Analysis (Fmea)
• Process Improvement
• Iso 13485
• Dmaic
• Manufacturing Engineering
• Quality Assurance
• Design for Manufacturing
• Electronics
• Validation