Karla A T.
About Karla A T.
Karla A T. serves as the Principal Regulatory and Compliance Engineer - Compliance Manager at Biosense Webster, where she focuses on quality improvement and compliance in the medical industry. With extensive experience in regulatory audits and quality management, she has held various engineering roles at Cordis and has achieved multiple certifications in quality assurance and regulatory standards.
Work at BioSense
Karla A T. has been employed at Biosense Webster as the Principal Regulatory and Compliance Engineer - Compliance Manager since 2019. In this role, she is responsible for external inspection readiness activities, which include the implementation of corrective and preventive actions. She leads quality improvement initiatives by executing quality audits and process assessments. Additionally, she establishes and monitors quality metrics to ensure alignment with organizational objectives. Her work focuses on enhancing the effectiveness of various improvement programs, including PDCA, Six Sigma, and Lean Techniques.
Education and Expertise
Karla A T. holds a Bachelor of Science in Industrial and Systems Engineering from Instituto Tecnológico y de Estudios Superiores de Monterrey, Campus Ciudad Juárez. She has achieved several certifications, including ISO 13485:2003 Lead Auditor and ISO 13485:2016 from BSI, as well as QSR 820 training from AAMI. She also obtained a Master Black Belt certification from J&J. Her educational background and certifications support her expertise in regulatory compliance and quality management within the medical device industry.
Background in Cordis
Prior to her current role, Karla A T. worked at Cordis for several years in various engineering positions. She served as Engineering Manager for Cardio Products from 2008 to 2012, and as an Industrial Engineer – Process Champion from 2005 to 2007. Additionally, she held the position of Manufacturing Engineer from 2003 to 2005 and worked as a Project Leader for Transfers for a brief period in 2007. Her experience at Cordis contributed to her extensive knowledge in managing external audits and regulatory compliance.
Achievements in Quality Improvement
Karla A T. has a strong track record in promoting and supporting quality, product, and process improvement projects. She analyzes the effectiveness of various improvement methodologies, including Six Sigma and Kaizen, to develop more effective methods for quality enhancement. Her responsibilities include evaluating, monitoring, and analyzing quality costs to maintain compliance with medical industry standards. She also advises on the issuance of policies, standards, and procedures to ensure adherence to regulations and external standards.
Regulatory Compliance Experience
Karla A T. possesses extensive experience in managing external audits from Regulatory Agencies and Notified Bodies. She participates in the execution and approval of engineering changes and is actively involved in ensuring the organization meets compliance standards. Her role requires a thorough understanding of regulatory requirements and the ability to implement corrective actions effectively. This expertise is crucial in maintaining the quality system within the medical device sector.