As a dedicated Quality Assurance Manager, I bring over 10 years of experience in maintaining and implementing robust Quality System procedures that ensure compliance with regulatory and corporate standards. My role as the Deputy Management Representative at the Brea site has equipped me with a comprehensive understanding of global regulatory requirements, including those from the FDA, China Health Canada, HPRA, JPAL, IVDD, IVDR, TGA, and ANVISA, as well as ISO 13485 standards.I take pride in leading external audits and ensuring that our site remains in a constant state of audit-readiness. My commitment to quality extends to facilitating Quality System Management Reviews (QSMR) and identifying trends in quality data for CAPA consideration, driving continuous improvement.As the manager and process owner of the CAPA process, I have honed my skills in training and mentoring CAPA owners, and developing an effective CAPA culture achieving and sustaining a 75% improvement in CAPA on-time-delivery.My oversight includes four direct reports and other local site quality processes including incoming/outgoing inspections, calibration, product non-conformances, and process and non-product software validations. I am passionate about maintaining a high standard of quality and compliance, and I thrive on the challenges that come with ensuring our operations meet the highest industry standards.I'm always eager to connect with fellow professionals and explore new opportunities to enhance quality assurance practices. Feel free to reach out if you'd like to discuss industry trends, best practices, or potential collaborations!