About Me

Lead Auditor ISO 9001 (CQI, IRCA certified)

I have been actively involved in Quality Assurance tasks since 1992. Over the course of a year-long tenure in the Medical/Food and machine/electronic industries, I have accumulated substantial expertise in Management, Quality Control, measurement techniques, Calibration, internal audits, supplier audits, project management, Corrective and Preventive Actions (CAPA), and the monitoring of regulatory requirements from ISO/FDA, Notified bodies, and customers.

My proficiency extends to areas such as supplier approval, quality agreements, design, and maintenance of Quality Management Systems. Additionally, I possess hands-on experience in the validation and qualification of both hardware and software, aligning with GAMP 5 guidelines. I have successfully navigated the intricacies of global Quality Management Systems within an international collaborative environment.

My familiarity with a diverse array of standards, including ISO9001, ISO14001, ISO45001, ISO50001, ISO27001, ISO13485, ISO17025, ISO31000, ATEX/IECEx 80079-34, and other regulatory requirements, underscores my comprehensive approach to quality assurance. Notably, I have served for more than 17 years in leadership roles, overseeing and being accountable for the QA Management function.