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

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