As a quality assurance consultant with twenty-five years’ experience in the biotech and medical device industry, Cinta Burgos ensures that client products are safe and effective. Cinta is the VP of Consulting Services at Azzur Group and all projects are now going through Azzur Group.
Cinta gained much of her knowledge of quality assurance and manufacturing operations while working with both large companies and small support. Prior to beginning her consulting business and the Biotech Box, she worked for CR Bard, NMT Medical, and as a validation engineer, R&D engineer, and laboratory assistant.
For clients, Cinta has conducted over a hundred supplier, internal and clinical audits. She facilitates and responds to FDA, EU and ISO 13485 notified body audits for manufacturers, and has a thorough knowledge of current good manufacturing practices (GMP), good laboratory practices (GLP), and regulatory compliance. Cinta relies on a hands-on approach to help her clients find efficient and effective methods for achieving approved product and process quality assurance goals. As a QA consultant, Cinta has supported GLP and GCP laboratories and studies, developed and maintained quality systems from design control/product development through cGMP manufacturing and commercialization, and conducted ISO, GMP, and GCP audits. In addition, she has been involved with quality by design, design control, risk management, development and clinical studies, testing and supplier identification/management, customer complaints and recalls, corrective action systems, training, due diligence, and regulatory submission support with a focus on product safety and efficacy.
Cinta is an adjunct faculty member of Tufts Veterinary School, holds a BS in Biophysics from UC San Diego and has completed graduate student level work in Mechanical Engineering. She serves on the Board of Directors of the American Society of Quality (ASQ) Biomedical National and Regional Groups, and is a life member of Society of Women Engineers.