QA Manager for Medical Devices

We’re seeking a QA Manager to oversee and enhance quality processes for our products and operations.

Location: Caesarea

Key Responsibilities:

– Implement and monitor cross-functional quality processes.

– Maintain and update QMS policies, including training and CAPAs.

– Upgrade and expand SOPs.

– Manage daily QA activities and company training.

– Prepare for and manage internal and external audits (CE, ISO 13485, FDA, etc.).

-Collaborate with regulatory bodies and consultants.

– Lead validation and risk management activities.

– Align QA goals with company strategy and regulatory requirements.

-Prepare and manage the QA budget.

B.Sc. in biomedical sciences, life sciences, engineering, or related field.

8+ years in QMS and regulatory affairs, including 3+ years in active medical devices.

Experience with CE, FDA, and ROW compliance.

Strong skills in English and Hebrew.

Proactive, detail-oriented, and able to manage multiple tasks.