Support and control of production and process controls of environment monitoring activities
Responsible on production batch files review and final release prior distribution
Support risk management activities including planning, design mitigations of production risk analysis,
and overall risk summary reporting (according to ISO14971).
Support transfer to manufacturing activities both in product development (NPI) and as well as sustain
released production line(s).
Responsible on elements of Quality system, including but not limited to, CAPA, production validations,
equipment qualification [IQ, OQ, PQ], nonconforming materials (MRB), design changes, leading and
investigating production and environment process failures and etc.
Support external and internal audits activities on site, drives site readiness activities.
Requirements: Bachelors degree with 1-3 years of professional experience in Medical Devices.
Knowledge and experience with: ISO 13485, QSR 820, ISO14971 and MDR.
Ability to work effectively in a changing and multi-tasking environment.
Good verbal and written communication skills with English fluency Mandatory.
Experience with electronic control system [DOT Compliance Suite] advantage.
Strong design/quality engineering skills with a proven track record in all process validation, equipment
qualification, calibration, design transfers, environment controls and production/process risk
management are strongly preferred
.המשרה מיועדת לנשים ולגברים כאחד