Elevating Quality and Regulatory Standards to New Heights
Yasily Ogando Roa is a distinguished figure in the ever-evolving realm of Quality Assurance and Regulatory Affairs, with a remarkable career that has left an enduring impact. With over 25 years of experience in developing and sustaining an organization’s quality strategy, procedures, and processes. Yasily’s journey is one of unyielding commitment to excellence and innovation.
Yasily’s journey to excellence began with a Bachelor of Arts degree in Computer Science from the Universidad Dominicana O & M in Santo Domingo, Dominican Republic, in 1990. Her thirst for knowledge did not stop there. She earned a Quality Engineering degree from Intec: Quality Council of Puerto Rico in August 1998, solidifying her foundation in quality management.
Yasily exhibits exceptional abilities that extend beyond her impressive academic qualifications. She boasts expertise in various critical areas, including FDA 21CFR part 820, and 803 regulations, ISO 13485 Medical Devices – Quality Management System, Good Manufacturing Practices (GMPs), and the Medical Device Single Audit Program (MDSAP). Her deep understanding of PPAP (Production Part Approval Process) and APQP (Advanced Product Quality Planning) core tools is instrumental in ensuring product quality and compliance. Moreover, her grasp of CE Marking, EU MDR, Unique Device Identifier -UDI, and GXP regulations is crucial for navigating the complex regulatory landscape.
Yasily Ogando Roa possesses a versatile skill set encompassing a wide spectrum of critical domains. With skills ranging from pharmacy licenses and product registration to regulatory inspections and audit programs, operational budget forecasting to leadership, strategic planning and quality business review. She combines her adeptness in staff training and development with exceptional presentation skills. Yasily’s leadership, coaching, and training capabilities shine through as she navigates the complex landscape of Quality Management System operations management. Her expertise in cost reduction and cost of quality is invaluable, particularly in the sectors of manufacturing medical devices, automotive, aerospace, and electronics. Yasily’s proficiency in compliance strategy development and process mapping applying lean manufacturing and continuous improvement exemplifies her ability to lead and innovate, making her a trailblazer in the world of quality assurance and regulatory affairs.
Yasily’s exceptional contributions to the Quality Assurance and Regulatory Affairs field have not gone unnoticed. In 2019, she was nominated as an Influential Woman in Manufacturing and Plant Services, a recognition of her pioneering work in the industry. This acknowledgment reflects her substantial impact on manufacturing and quality practices.
In July 2023, her outstanding leadership was acknowledged with an Outstanding Leadership Award by the Health 2.0 Conference. This prestigious award underscores her status as a trailblazer in the field, with her leadership leaving a lasting imprint.
Yasily’s journey to excellence is marked by a commitment to continuous learning and a relentless pursuit of excellence. Her dedication is exemplified by her ongoing pursuit of a Regulatory Affairs Certificate for Medical Devices through RAPS Online University. This commitment to staying current with the latest in regulatory affairs showcases her dedication to professional growth and industry knowledge.
Boasting a wealth of knowledge and expertise, Yasily has honed through significant tenures at esteemed organizations. Her tenure as the Vice President of Quality and regulatory Affairs at Drive DeVilbiss Healthcare in Port Washington, NY, exemplifies her ability to lead and innovate on a grand scale. Here, she executed and maintained an innovative Quality Management System (QMS) following FDA 21CFR Part 820, ISO13485, MDSAP, and other regulatory requirements under the medical device industry. She is responsible for quality operations, systems, and regulatory affairs across the company, including corporate headquarters as well as domestic and international distribution centers and USA manufacturing sites.
Yasily’s dedication to quality and regulatory affairs is further demonstrated by her previous role as the Director of Quality Assurance at Leviton Manufacturing Company in Melville, NY. She oversaw international and domestic manufacturing plants and Distribution Centers, with responsibilities including maintaining a closed-loop customer complaint process and deployment of APQP quality methods.
At Volkert Precision Technologies in New York, where she served as Quality Manager & Management Representative, Yasily led the site, monitored, and continually improved all aspects of the Quality Management System. She coached and mentored the QMS to assure the achievement of company quality goals.
Yasily Ogando Roa’s journey is marked by excellence, innovation, and dedication. Her multifaceted leadership extends across international borders, as she leads organizations to achieve and maintain the highest standards of quality, safety, and compliance.
As she continues to learn, innovate, and lead, Yasily stands as a beacon of excellence and a role model for those in pursuit of the highest standards in Quality Assurance and Regulatory Affairs. Her journey is an inspiration, and her impact is immeasurable, making her a true pioneer in the field.