Quality System Senior Specialist

This hybrid position is based in Yokneam, Israel/Santa Clara, California/ Lafayette, Colorado facilities. The role requires occasional travel and involves independent work to maintain quality standards across global operations.
Responsibilities may include the following and other duties may be assigned:

Provide oversight for development and maintenance of quality management systems, ensuring full compliance with FDA, ISO 13485, and other regulatory requirements
Lead audit and inspection preparation activities, coordinate with regulatory bodies, and manage resolution of findings through comprehensive Corrective and Preventive Actions (CAPA)
Conduct process analysis and risk assessments to identify improvement opportunities and ensure adherence to quality standards across manufacturing and design operations
Collaborate with cross-functional teams to interpret regulatory requirements and implement quality policies that support our endoscopy and surgical device portfolios
Prepare detailed quality reports and documentation for internal stakeholders and external regulatory agencies
Facilitate global quality standards implementation and best practice sharing across international sites

R41483