מנהל /ת איכות

מיקום המשרה: תל אביב יפו ,  הרצליה ,  רעננה ,  נתניה ,  קיסריה  תחומי המשרה: אבטחת איכות qa ,  מנהל איכות | מנהל QA  סוג / היקף המשרה: משרה מלאה ,  לדוברי אנגלית  Implementation of a quality management system in compliance with ISO: 13485:2016 and FDA requirements ( QSR ) Manage all qa aspects of the company including CAPA processes internal and external audits , management reviewSupport Design and Development activities in different stages: design input , output , V V , ECOsMaintain DHFSupport V V planning and execution ( Biocompatibility , performance , packaging , transportation , shelf life and sterilization validation ) Risk management ( DFMEA , AFMEA , PFMEA ) Design transfer and DMRAssistance in clinical trials managementRequirements: Minimum 2 years of qa experience in the medical device industry ( design control experience is an advantage ) bsc in Bio-Medical / Mechanical / Biotechnology Engineering / Exact SciencesStrong written and verbal communication skills in English המשרה מיועדת לנשים ולגברים כאחד .