For the QA/RA Position:
Experience with mechanical implants (orthopedic / dental / cardio- vascular IMPLANTS)- mandatory
Experience with Notified Bodies.
Experience with quality assurance requirement.
FDA / CE approval experience and passing an Audit.
To establish, maintain and improve the quality system in accordance with 21CFR820, ISO9001 and ISO13485 .
Class IIB or Class III experience.
דרישות:
For the QA/RA Position:
Experience with mechanical implants (orthopedic / dental / cardio- vascular IMPLANTS)- mandatory
Experience with Notified Bodies.
Experience with quality assurance requirement.
FDA / CE approval experience and passing an Audit.
To establish, maintain and improve the quality system in accordance with 21CFR820, ISO9001 and ISO13485 .
Class IIB or Class III experience.