Rigo Guzman
Sr. Quality Engineering Manager- Quality Management System, Compliance Leader, EU MDR/ IVDR digital transformation, Quality Engineering, Risk Management, Regulatory Affairs, Project Manager
- Role
- Program Manager at BD
- Location
- Irvine, CA, US
- LinkedIn followers
- 500 followers
About Rigo Guzman
With over 15 years of progressive experience in the Medical Device (ClassI, Class II and AIMD, Capital Equipment Manufacturer, SAMD), Pharmaceutical, and Diagnostic industries, I bring a wealth of knowledge to support all stages of Medical Device companies. From Quality Assurance (QA) and Regulatory Affairs (RA) to leadership development, my expertise covers the full spectrum of industry needs.A strategic thinker, with a proven track record of- Reduce complaints by 30% through Six Sigma process enhancements - Lead ISO 13485, FDA 21 CFR 820, and MDSAP Compliance programs across multiple companies - Quality Assurance, Regulatory Strategy, and Product Lifecycle Management- Mediating problems to resolution in a timely mannerI am passionate about driving organizational excellence and ensuring compliance across all stages of product development and commercialization. Whether it’s developing robust QA systems, navigating intricate RA requirements, audit readiness preparation, QMSR transition activities, QMS remediation activities, due diligence projects or building and leading teams to success, I am committed to supporting the growth and innovation of Medical Device companies.
Experience
Program Manager
Oct 2025 — Present · Irvine, CA, US
Leading cross-functional NPD and sustaining engineering programs from concept through commercialization at one of the world\'s largest medtech companies. Own end-to-end program execution across engineering, quality, regulatory, operations, and manufacturing — building critical path schedules, governing phase-gate design control compliance (21 CFR 820 / QMSR / ISO 13485), managing DHF completeness, and assessing quality and validation impact of change orders (ECOs/SCOs/ECRs).
Education
Concordia University Irvine
Master of Business Administration - MBA, Operations Management
California State University, Fullerton
Cert, Pharmaceutical Engineering
UC Irvine
Certificate, Medical Product Development
California State University, Long Beach
B.S, Mechanical Engineering
California State University, Fullerton
Certificate, Green Belt Plus Six Sigma
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