Ensure that the organizations’ Quality Management System conforms to customer, internal, ISO 13485, FDA, European Medical Devices Directives, Canadian Regulations, RDC 665/22 and other regulatory/legal requirements, Conduct and oversee the Internal Audit Program to establish and implement Corrective Actions and modifications to the QMS Documentation. Oversee Management of Change compliance. Report to management on the performance of the QMS. Oversees the maintenance of the QMS (Quality Management System) and ensures documentation (Quality Manual, SOPs, Work Instructions, GMP, GDP) in compliant with FDA regulations, ISO 13485:2016, 14971:2019 and MDR 93:42 Coordinate responses to any regulatory changes required. Advice executive leadership and company peers on improvement opportunities. Liaised with Managers/external-assessment bodies on all Quality Management System matters.

President of Zucci Consulting Services, LLC. Develops, Trains, audits, maintains and consults on management systems for ISO 9001 (Quality), ISO 29001 (Oil & Gas), ISO 13485 (Medical Devices), and ISO 27001 (information Security Management Systems).Lead Auditor ISO 9001:2015ASQ-Member

* Oversee and maintain the Quality Management System of the Company (ISO 9001 & ISO/TS 29001). * Work closely with executives and process owners to develop their processes, documentation, quality objectives and KPIs .* Ensure the internal audit program is effectively implemented and maintained. Report and write Nonconformity Reports.* Oversee CAPA System and usage of root-cause analysis (RCA) tool. Updating risks and opportunities..* Oversee the Company’s incident management system (processing and solving time).* Oversee the Management of Change and Document Control.* Liaise with external assessment body on all matters related to Quality Management System.* Facilitate and promote the Continual Improvement, risk-based thinking and process approach across the organization.

Purchasing andQMS Manager