Experience in creation, implementation, and maintenance of the QMS, in compliance with the various global regulatory regions, in addition to the EU technical files management and execution of key validation processes such as SMT and Assembly Processes.

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Prior to BioVision, Simona functioned as Viora Ltd. QA & RA Director, where She had fully submitted new products to FDA, CE, and other regulatory regions, in addition to the QMS main activities ( CAPA, Trainings, Risk Management, Reviews, Supplier Audits, etc.)

 

Before Viora, Simona had been employed at Medimor and PCB Electronics as a QA Engineer, specialized in the process validations for the medical device customers at these companies.