לצערנו המשרה כבר לא בתוקף

QA Engineer - בתחום המדיקל

1-2 שנים |
משרה מלאה
| 10/05/2021
תיאור משרה

Qualitest is the world's largest, independent managed services provider of quality assurance and testing solutions.
We’re looking for a QA Engineer to join our team!
This is a full-time position in Kefar Sava.
Conduct QA activities relating to data analysis, KPIs and statistics
Performed periodical Internal Audits
Maintain CAPA and Non-conforming activities
Maintain the equipment calibration system
Review and approve deliverables and additional documents which are required for the R&D projects
Act as a QA representative of change controls initiated throughout the R&D products and changes related to the QMS
Maintain the products failure analysis activities results from: complaints and returned products (RMA)

דרישות התפקיד

1. B.Sc in Engineering in one of the following fields: Quality\Biomedical\Biotechnology or in Bioscience education
2. Certified Quality Engineer (CQE) – advantage
3. At least 2 years experience in QA or RA, preferably with R&D projects in a medical device or company according to GMP and regulatory requirements (FDA QSR 820, ISO 13485)
4. Experience working in medical device product development (product design) and manufacturing (process design, process validation and production)
5. Background with multi-disciplinary products: Software, Hardware, Mechanical
6. Auditor qualification - an advantage
7. Full control of all MS-Office applications
8. Ability to work in Multidisciplinary work opposite various stakeholders internally and externally
9. Fluent English – writing and verbal