Leslie Oliveira
About Leslie Oliveira
Leslie Oliveira is a Senior Analyst in Quality Management and Medical Devices at MEDITECH, where she has worked since 2014. She holds a Bachelor of Arts in Sociology and an ASQ certification, and has extensive experience in quality management systems and compliance with FDA standards.
Work at MEDITECH
Leslie Oliveira has been employed at MEDITECH since 2010, initially serving as Supervisor of LIS Applications for four years. In 2014, she transitioned to the role of Analyst in Quality Management, where she has worked for ten years. In 2017, she advanced to the position of Senior Analyst in Quality Management and Medical Devices, a role she has held for seven years. In her current position, she provides oversight and guidance on the development and use of registered Class I and Class II Medical Devices, ensuring compliance with FDA standards.
Education and Expertise
Leslie Oliveira holds a Bachelor of Arts in Sociology from the University of Massachusetts Dartmouth, which she completed from 2004 to 2008. She is also pursuing an Associate's Degree in Baking and Pastry Arts at Johnson & Wales University, a program she has been engaged in since 2014. Additionally, she holds the ASQ Certified Manager of Quality/Organizational Excellence certification, demonstrating her expertise in quality management.
Background in Quality Management
Before joining MEDITECH, Leslie Oliveira worked at Fellowship Health Resources. She served as a Mental Health Counselor from 2006 to 2008 and then as a Quality Improvement Specialist from 2008 to 2010. Her experience in these roles contributed to her knowledge in quality management and improvement processes.
Quality Management Systems Implementation
In her role as Senior Analyst, Leslie Oliveira leads the implementation and continual improvement of the Quality Management System (QMS) program. She ensures compliance with ISO 9001:2015 and FDA 21 CFR 820 standards. Her responsibilities include serving as an expert in Root Cause Analysis, Corrective and Preventive Actions (CAPA), and Incident Reporting processes.
Training in Regulatory Compliance
Leslie Oliveira is trained in FDA Inspection, Recall, and Warning letter processes. This training enhances her ability to navigate regulatory requirements and maintain compliance within the medical device sector.