תיאור המשרה:
לסטארט אפ באזור השרון בתחום המדיקל דיוויס (מולטידיסיפלינארי) דרוש/ה מהנדס/ת איכות ורגולציה.
העבודה בצוות והתפקיד כולל:
Document Control Center (DCC) – manage documents changes, approvals and release
Customer Complaints – document complaints and collaborate in complaints investigations
CAPAs/SCARs – initiate and manage CAPAs and SCARs
ECO – initiate and manage ECOs
Assist in QA projects and regulatory submissions
דרישות:
2 years of experience in QA&RA, preferably in DCC / CAPAs / ECOs / Complaints, from a software medical device company regulated under ISO13485
Knowledge in ISO13485, FDA QSR, and EU MDD/MDR requirements
Excellent communication skills in Hebrew and English, written and verbal
B.A or B.Sc. degree
Experience with ISO27001 requirements
