Guillermo Monay
Quality Assurance Manager @ NIHON KOHDEN OrangeMed | Ensuring Quality and Compliance in Manufacturing
- Role
- Quality Assurance Manager at NIHON KOHDEN OrangeMed
- Location
- Huntington Park, CA, US
- LinkedIn followers
- 500 followers
About Guillermo Monay
Accomplished Quality leader with 25+ years of experience driving end to end Quality Assurance, Design Assurance, and Quality Systems Management for Class I & II medical devices. Proven ability to lead large QA/QE/QC teams, elevate manufacturing and supplier quality performance, and deploy scalable QMS solutions aligned with FDA 21 CFR 820, QMSR, MDR, MDSAP, ISO 9001/13485, and ISO 14971 requirements.Brings deep expertise in risk management, CAPA governance, technology transfer, and cross functional quality integration across R&D, Operations, Supply Chain, and Regulatory. Adept at building KPI driven quality programs, preparing for global regulatory inspections, and advancing organizational maturity through Lean, standardization, and data driven continuous improvement.Ideal for roles requiring a strategic quality architect who can strengthen compliance, improve operational performance, develop talent, and partner with executive leadership to deliver safe, effective, and reliable products at scale.
Experience
Quality Assurance Manager
Mar 2026 — Present · Santa Ana, CA, US
In my role at NIHON KOHDEN OrangeMed, I spearheaded the Quality Assurance team, ensuring compliance with QMS and overseeing quality engineering support for manufacturing operations. I actively participated in new product development and risk management activities, collaborating with various departments to resolve quality issues and drive continuous improvement initiatives. My leadership contributed to maintaining high standards of quality and regulatory compliance.
Education
California State Polytechnic University-Pomona
Bachelor of Science (BS), Mechanical Engineering
2000 — 2004
California State University-Dominguez Hills
Master of Science (M.S.), Quality Assurance:Manufacturing
2012 — 2016
Skills
- Iso 13485
- Design of Experiments
- Medical Devices
- Fda
- Design Control
- Capa
- Fmea
- Iso 14971
- Quality System
- V&V
- Minitab
- Dmaic
- Spc
- Design for Manufacturing
- Validation
- Continuous Improvement
- Statistical Process Control (Spc)
- Verification and Validation (V&V)
- Corrective and Preventive Action (Capa)
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