Responsibilities

• Responsible for quality-related aspects, such as QMS, Document control.
• Overall responsibility for the Validation and Verification process (Plan, protocol, report).
• Write and implement company procedures – Hands on.
• Review and approve deliverables and additional documents which are required for the R&D, Engineering, and Manufacturing projects.
• Handling non- conformities detected in production and participating in the MRB committee.
• CAPA processes management.
• Perform internal and external audits.
• Working and communicating with suppliers /subcontractors in Israel and abroad, on production quality issues.
• Responsibility for equipment calibration activities.
• Ongoing monitoring of quality goals, ensuring data is appropriately analysed, reported, and evaluated.
• Support Change Control activities as a QA representative.

Requirements

• A minimum of a bachelor’s science or engineering degree is required.
• CMQ/CQE or similar – an advantage.
• At least 2 years of experience in working according to GMP and regulatory requirements (FDA QSR part 820, ISO 13485).
• Knowledge and experience with quality processes, preferably with handling Non-Conforming and CAPA processes, in a medical device company.
• Proficiency in Office products – Must.
• Strong written and verbal communication skills communicate freely with executives in both English and Hebrew.
• Willing to travel abroad.