ABOUT OUR LEAD AUDITOR
Quality Systems & Compliance Professional-Lead Auditor
Yvette Gonzalez-Cuascut is a Quality Systems and Compliance professional. She is a certified Lead Auditor for ISO9001:2015 and ISO13485:2016 with over 20 years’ experience working in Medical Device, Biotechnology, Nutrition Consumer Health Products and pharmaceuticals in the US, Caribbean, Europe, Singapore and South Korea.
Mrs. Gonzalez-Cuascut has held leadership roles in Quality Management Systems (QMS) remediation projects, consultancy and auditing. She has conducted regulatory audit services using 21 CFR Parts (820, 210, 211, 11), ISO (13485, ISO9001, ISO17025, ISO11135) and Mexican Norm for companies such as: TEVA Pharmaceuticals, Roche Diagnostics, Oscor Inc.and others. She has developed and implemented programs for: QMS, internal and regulatory audits, training, document controls, procedures development, quality records review, investigations for: CAPA, Non-Conformance, Complaints, SCARs, Suppliers and Purchasing Controls for companies such as: Samsung, Ben Venue laboratories and Oscor Inc. Also, she has conducted Human Reliability Consultancy and assessments. Rendered consultancy and assessments for Human Error detection, investigations, root cause determination, CAPA implementation for: Ethicon, Bausch and Lomb, Bristol Myers Squibb and Abbott Nutrition/Pharmaceutical.
She has full Knowledge on current 21 CFR Part 820, 210, 211, 11, Data Integrity guidelines, ISO11135:2014 and ISO17025:2017 and strong experience in Human Error solutions.
Yvette obtained her bachelor’s degree in Chemistry from Pontifical Catholic University of Puerto Rico. Additionally, Yvette has ISO13485:2016 and ISO9001:2015 Lead Auditor certifications.
Her key competencies include: quality systems compliance management, quality systems audits (Internal, FDA, ISO, Customers), suppliers audits, problem solving – DMAIC, nonconformance investigations, CAPA, quality controls, complaints, SCARs, procedures writing, quality systems records review, training, supplier qualifications, suppliers’ and purchasing controls; words, excel, power point proficient. Coach and train auditors and investigators.