My coworkers say I am passionate about quality because I focus on high integrity to ensure projects are completed to meet the highest specifications. “Good Enough” is not in my vocabulary.I am described as a Critical Thinker and Quality Leader who has extensive experience in Quality Management and Regulatory Affairs in the medical device industry.One of my talents is the ability to comprehend complex and abstract systems to assist with solutions. This has enabled me to transform business operations by elevating to a quality culture through instilling a focus on quality within every level of the organization. As a people-oriented leader, I drive teams to successful completion in the areas of compliance audits, QSR, ISO9000 and ISO13485, EO sterilization, and multiple quality tools and systems integrations.QUALITY CULTURE DEVELOPMENT – Contributed to development of the Stellar Technologies Quality culture by establishing standards and motivating staff to achieve quality goals.QUALITY PROCESS & SYSTEM INTEGRATION – Integrated quality system and ISO processes after Cirtec Medical acquisition of $5.5M local stamping company.ISO CERTIFICATION: MEDICAL DEVICES – Instituted new processes to achieve certification of ISO13485:2016 for Cirtec Medical.START-UP EXPERIENCE – Led key role in the SterilMed start-up organization, executing and establishing all aspects of quality and regulatory functions for company, encompassing ISO certification processes, policies and procedures, corrective action programs, FDA submissions, FDA audits and employee training systems.STERILIZATION PROCESS – Established and validated process EO sterilization cycle for a magnitude of medical devices for SterilMed. Developed system for routine Bioburden studies. CORRECTIVE & PREVENTIVE ACTION (CAPA) PROGRAM DEVELOPMENT – Designed SterilMed’s Corrective and Preventive Action program and implemented, documented, and performed troubleshooting as needed via customer feedback.