Quality Assurance Specialist

QA Specialist | Medical Device Company | Caesarea, Israel

A leading medical device company is looking for a QA Specialist to join the Quality team. The role includes ongoing work with the Quality Management System (QMS) and supporting quality processes across Manufacturing and R&D.

Location: Caesarea, Israel

Responsibilities

Support and implement quality processes within the QMS

Manage Change Control processes and document control activities

Write and implement quality procedures and work instructions

Support CAPA processes and Non-Conformances (NC) investigations

Work with eQMS systems, labeling processes and UDI requirements

Prepare for and support internal and external audits

Analyze quality data, track KPIs and support Management Review activities

Collaborate with multiple cross-functional teams across the organization

Requirements

At least 3 years of experience in Quality Assurance within a medical device company

Hands-on experience working with a Quality Management System (QMS)

Strong familiarity with regulatory standards and requirements including FDA, ISO and MDR

High level of English – reading, writing and speaking

Strong organizational skills with the ability to work independently as well as part of a team