We're seeking a QA Manager to oversee and enhance quality processes for our products and operations.
Location: Caesarea
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.
Requirements:
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.
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.
This position is open to all candidates.
