תיאור תפקיד:
We are a service provider company, leader in the Pharmaceutical and Medical Device sectors since 1998. With more than 900 employees all over the world (Europe, Asia and the Americas) and 25 subsidiaries, joining PQE means join a multicultural and challenging company in which you will be not only involved in international projects but you'll also have the chance to get in touch with colleagues from all over the world. For more information, visit our web page at www.pqegroup.com
Due to a constant growth, PQE is looking for a Medical Device Consultant
based in our office in Ness Ziona, Israel
Responsibilities will include:
- Guide and support execution of compliance projects in Medical Device area
- Bring new expertise in quality management and regulatory affairs for Medical Device
- Enhance PQE services in Medical Device area
- Perform internal audits, according to ISO 13485 and 21 CFR 820
- Manage complaints and submit them to Manufacturer
- Coordinate execution of Recalls
- Develop and maintain local QMS for ISO 9001, ISO 14001, ISO 22301 and ISO 45001 certification
- Manage Non-conformities and CAPA
- Deploy internal Training
- Interact with manufacturing sites for any issue impacting compliance
דרישות:
Requirements:- 2/4 years of experience in MD QA related positions - Medical Device Requirements for Quality Management System (21 CFR part 820, ISO 13485) - MDR 2017/745 - EU and Extra EU MD registration processes (CE marking, 510(k), PMA) - Experience in dealing with FDA Risk Management for Medical Devices Location: Ness Ziona, Israel
היקף משרה:
משרה מלאה
קוד משרה:
JB-00038
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