Irene Mo has extensive work experience in quality management and regulatory affairs. Irene is currently serving as the VP of Quality & Regulatory at miraDry, Inc. Prior to this, they held positions such as Head of QMS, Image Guided Therapy Devices at Philips (formerly Spectranetics), and Sr. Manager, Quality Systems at Spectranetics. Irene also worked as the Director of Quality at RMB Products, Inc., and as Sr. Quality Assurance Manager and Quality Engineering Manager at ZELTIQ.
Before joining ZELTIQ, Irene worked at Solta Medical, Inc. as the Manager of Quality Systems and Sr. Quality Engineer. Their responsibilities included leading internal audits, coordinating Quality Review Board meetings, managing CAPAs, and implementing new Quality Management System procedures.
Earlier in their career, Irene worked at JOHNSON AND JOHNSON, Conor Medsystems, where they served as a Senior Quality Systems Engineer/Supervisor and managed CAPA, Change Management, Document Control, Records Management, and Microbiology quality systems. Irene also worked at WW Quality Systems as a Quality Assurance Engineer II and Quality Assurance Engineer I, where they partnered with different departments to develop and deploy the global Nonconformance electronic system, conducted root cause analysis, and conducted monthly meetings.
Irene began their career as a Supplier QA Engineer at Kelly Consulting Services, where they focused on implementing corrective/preventive actions for external manufacturers and suppliers based on FDA audit observations.
Irene also has experience as a Structural Engineer Intern at Hazen and Sawyer, where they managed projects for wastewater treatment plant upgrades and coordinated drafting changes.
Overall, Irene Mo has a strong background in quality management and regulatory affairs, with a focus on internal audits, CAPAs, and the implementation and improvement of quality management systems.
Irene Mo completed their Bachelor of Science degree in Civil Engineering from the University of Miami between the years 2000 and 2004. Irene then pursued further education at the University of Miami Herbert Business School from 2007 to 2008, earning an Executive MBA. Additionally, during this time, they also obtained a Master of Science degree in Industrial Engineering from the University of Miami, which they completed between 2007 and 2009.
In terms of certifications, Irene Mo obtained the Certified Quality Engineer (CQE) certification from ASQ in June 2014. Irene also achieved the Certified Quality Manager/Organizational Excellence certification from ASQ in March 2014. Additionally, they obtained the Certified ISO 13485 Lead Auditor certification from BSI in March 2013.
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