Monique Zamora
About Monique Zamora
Monique Zamora serves as the Director of Quality Engineering & Regulatory Compliance at Breg, where she has worked since 2021. She has extensive experience in quality engineering and regulatory compliance, with a background that includes roles at several companies and a strong educational foundation in biology.
Current Role in Quality Engineering and Regulatory Compliance
Monique Zamora serves as the Director of Quality Engineering & Regulatory Compliance at Breg, a position she has held since 2021. In this role, she oversees quality engineering initiatives and ensures compliance with regulatory standards. Her responsibilities include managing quality assurance processes and leading teams to meet industry regulations.
Previous Experience at Breg
Zamora has held multiple positions at Breg, including Sr. Principal Quality Engineer from 2012 to 2016 and Quality Engineering Manager from 2018 to 2020. She also served as Sr. Quality Engineering Manager for one year from 2020 to 2021. Her tenure at Breg has contributed to her extensive expertise in quality engineering and regulatory compliance.
Educational Background in Biology
Monique Zamora studied at San Diego State University, where she earned a Bachelor of Applied Science (BASc) in Biology from 1997 to 2000. This educational foundation has equipped her with essential knowledge relevant to her career in quality engineering and regulatory compliance within the medical device industry.
Quality Assurance Experience
Zamora has a diverse background in quality assurance, having worked at several organizations. She was a Quality Assurance Specialist at Alpharma from 2003 to 2004, a Staff Quality Assurance Scientist at Beckman Coulter from 2005 to 2012, and a Quality Assurance Manager at DNA Electronics from 2016 to 2018. This experience has strengthened her skills in quality management and regulatory compliance.
Certifications and Expertise
Monique Zamora holds a Six Sigma Certification, demonstrating her proficiency in process improvement methodologies. She possesses in-depth knowledge of regulatory compliance, particularly with FDA QSR 21 CFR 820 and cGMP standards, as well as ISO 13485 and ISO 14971 standards, which are essential for medical device quality management systems.