תיאור
Be the QA focal point design and development of projects throughout the product design process until transfer to production
Provide quick solutions to inquires and problems arising during the process
Control all aspects of project documentation
Interface with relative personnel to resolve document problems/issues within the design process
Be a customer facing team member and represent the organization and QA needs to the customer
Assist in cases of non-conformities (NC) of products, parts and processes
דרישות
Practical Engineer/ B.Sc. in Quality/ Biomedical/ Biotechnology or similar - an advantage
CMQ / CQE or similar - an advantage
Job skills:
At least 2 year of experience in working according to GMP and regulatory requirements (FDA QSR part 820, ISO 13485) – mandatory
Previous experience in QA design work – significant advantage
Experience with QMS and production - significant advantage
Experience in the field of Medical Devices - an advantage
Computer skills:
Acquaintance with E-Document management systems
