Keeps abreast and complies with international standards requested and regulatory requirements.
Quality Management System Maintenance .
Preparing/Updating procedures/ WIs .
Control of documents/records .
Internal audits, Suppliers audits.
Non-conformance control, CAPA.
Develop and Monitor Performance Metrics for All Stages of the Production Process.
V&V of equipment.
Customer complaints investigation and analysis.
MDR Gap Analysis and preparation .
Labeling Compliance
Technical files preparation and maintenance .
PRRC.
Risk Management activities.
Registrations/license renewal (Israel and worldwide).