QA Leader

03/01/2021

תיאור

לסארטאפ בתחום המדיקל באזור ירושלים

דרוש/ה QA Leader

The QA Leader shall be the leading support to QA\RA VP in the management of the Quality Management System.

He \ She will be responsible for the establishment and maintenance of the Quality Management System.

She \ He should be able to translate the requirements of ISO13485: 2016, 21CFR820, MDSAP and other QMS standards related to medical devices.

This position will require:

• Procedures writing and implementation

• Establishing and executing internal audits

• CAPA Management

• NCRs management

• Suppliers quality management (suppliers scores, audits, process validation, SCARs management)

• Data analysis

• Action items follow-up

• Experience: 2-3 years in QA, preferably - Medical Devices

• Education: B.Sc. in Engineering, preferably – Industrial/Mechanical/BioMedical Eng. From a known university or leading college

• Skills: procedure writing, employee training, statistical analysis, good presentation capabilities