Quality Assurance Manager

Sion Medical Ltd is looking for a passionate and experienced Quality Assurance Manager to join our team and lead QA operations in our medical device manufacturing activities.

Responsibilities:

• Maintain and implement all quality requirements according to ISO 13485, ISO 9001, and applicable product standards.
• Write and update SOPs and work instructions based on regulatory, standard, and customer requirements.
• Manage daily operations of the QA department and the Quality Control (QC) team.
• Oversee supplier quality management, including audits, approvals, and ongoing assessments.
• Handle customer satisfaction processes – including complaint management, root cause investigations, corrective actions, and effectiveness reviews.
• Identify and resolve quality issues with the production team, implement corrective and preventive actions, and monitor their effectiveness.
• Planned and conducted internal audit programs and employee training.
• Monitor and report on key quality KPIs and prepare and present annual management reviews.
• Lead continuous improvement of QA & QC department.

Requirements:

• B.Sc. in Sciences or a relevant field – mandatory
• Minimum 3 years of QA experience in the pharmaceutical, medical device, or food industry – mandatory
• Minimum 3 years of experience managing QA/QC personnel – mandatory
• Certified Internal Auditor – advantage
• Proven experience with ISO standards implementation – mandatory
• High proficiency in Microsoft Office – mandatory
• Experience with Priority ERP – advantage

Languages: Hebrew – high level | English – High level

Full-time position | Excellent conditions for the right candidate.