QA Operation Engineer

Benatav, a leading company in the production of miniature coils for the medical device industry, is expanding its team. We are looking for a QA Operation Engineer to join our quality department in an exciting and challenging role. If you are passionate about quality assurance and eager to contribute to cutting-edge medical technology, this opportunity is for you!

Responsibilities:

• Monitoring customer quality requirements as outlined in work documents, such as quality agreements or Statements of Work (SOW), and integrating them into company processes.
• Managing interactions with various customers, both domestically and internationally, on quality-related matters such as engineering changes (ECO), overseeing products at different production stages, addressing customer quality requirements, and providing feedback between the company and customer representatives.
• Analyzing production processes and data, conducting investigations with analytical precision, focusing on NCRs, CAPAs, and MRBs.
• Addressing quality issues in production and managing periodic quality findings.
• Leading, Investigations, Customer Complaints, establishing and implementing Corrective and Preventive actions.
• Managing software validation, from protocol development to implementation (not mandatory).
• Supporting and accompanying customer audits, certification audits, , and conducting supplier and internal audits.
• Training employees and providing support to colleagues in the quality department to fulfill their responsibilities.
• Performing additional quality-related tasks as needed, such as: Suppliers approval, Management review, Supplier evaluation, KPI.

Requirements:

• B.Sc. in Engineering or Practical Engineering Diploma, with relevant QA courses.
• 3-5 years of experience in quality assurance, with proven knowledge of validation processes (preferably in the medical device manufacturing field).
• In-depth knowledge of ISO 13485 standards and regulatory requirements for medical devices.
• Familiarity with Priority ERP systems and engineering information systems – an advantage.
• High-level proficiency in English (both written and spoken).
• Proven ability to prioritize tasks effectively, demonstrate a strong work ethic, excel under pressure, and maintain excellent interpersonal skills.