Manage and maintain the companys Change Control system for product design, manufacturing,
software, and quality documentation.
Coordinate cross-functional Change Review Board (CRB) meetings to evaluate and approve change
requests.
Ensure all change documentation (e.g., ECRs, ECOs, DHF, DMR updates) meets regulatory and
internal quality system requirements.
Implement and monitor Configuration Management (CM) practices to ensure product
configurations are accurately defined, documented, and traceable.
Maintain revision control of engineering drawings, specifications, BOMs, and other controlled
documents in Priority, PDM and eQMS systems.
Collaborate with R D, Manufacturing, Operations, Suppliers, Quality, and Regulatory teams to
ensure changes are effectively communicated and implemented.
Support internal and external audits by providing documentation and demonstrating adheren
Requirements: Education: Bachelors degree in Engineering, Quality, or related scientific discipline.
Experience: 3-5 years of experience in change control and configuration management in a
manufacturing of multidisciplinary products, in a quality system environment (ISO 9001 at
minimum) preferable in a medical device company.
Experience supporting product development, NPI and commercial products in the aspect of change
and configuration management.
Familiar with:
o FDA QMSR
o ISO 13485
o ISO 14971 (Risk Management)
Technical Skills: Experience with Priority, PLM and eQMS. Proficiency with MS Office and document
management systems.
Strong attention to detail, organizational skills, and ability to work in a cross-functional
environment.
Excellent written and verbal communication skills in Hebrew and English (mostly written skills).
This position is open to all candidates.