Ana Luttmann

About Ana Luttmann

Quality & Regulatory Executive with 20+ years of experience leading and governing quality organizations. I specialize in building, stabilizing, and scaling Quality Management Systems that support regulatory compliance, inspection readiness, and successful commercialization.I have led quality strategy and execution across early-stage through commercial organizations, supporting Class II and Class medical devices. My experience spans proactive compliance, enterprise QMS development, FDA and global regulatory inspections, and remediation of high-risk quality challenges. I have served as a trusted partner to executive leadership teams, providing clear guidance on regulatory risk, quality governance, supplier oversight, and post-market surveillance.

Experience

1. Senior Vice President, Quality

   Sq Innovation

   Jan 2026 — Present

   Provide leadership for the Quality organization, overseeing GxP compliance across pharmaceutical and medical device operations.

Education

• Universidad Rafael Landívar

  B.S., Chemical & Industrial Engineering

Skills

• Iso 14001
• Quality System
• Quality Systems
• Quality Management
• Food Safety
• Process Engineering
• Management
• Internal Audit
• Quality Control
• Gmp
• Auditing
• Testing
• Iso 13485
• Root Cause Analysis
• Cpsia
• Process Improvement
• Inspection
• Iso
• Sop
• Accreditation
• Tqm
• Continuous Improvement
• Compliance
• Project Planning
• Six Sigma
• Iso 17025
• Quality Auditing
• Spc
• Supplier Quality
• Capa
• Engineering
• Iso 9000
• Iso 9001
• Validation
• Fmea
• Quality Assurance