Location: Caesarea
A leading Medical Device company is looking for a QA Specialist for a significant role within the Quality department. The position involves ongoing work with the Quality Management System (QMS) and supporting production and R&D processes.
Responsibilities:
- Supporting and implementing quality processes within the QMS.
- Managing Change Control processes and document control.
- Writing and implementing Quality Standard Operating Procedures (SOPs).
- Overseeing CAPA processes and Non-Conformance (NC) management.
- Working with eQMS systems, labeling, and UDI.
- Preparing for and managing internal and external audits.
- Data analysis, KPI tracking, and preparing Management Reviews.
- Ongoing collaboration with multiple interfaces across the organization.
Requirements:
- At least 3 years of experience in Quality within the Medical Device industry.
- Hands-on experience working with QMS.
- In-depth knowledge of standards and regulations: FDA, ISO, MDR.
- High-level English (reading, writing, and speaking).
- Organized approach, with the ability to work both independently and as part of a team.