Quality Engineer

About the role

Johnson & Johnson MedTech is seeking a Quality Engineer to support its Cardiovascular product family in Yokneam, Israel. The role focuses on end‑to‑end quality management, from supplier selection through production and product lifecycle, ensuring compliance with medical device standards.

Key responsibilities

• Support quality activities during transfer to production and ongoing manufacturing.
• Manage process validation and verification, including supplier guidance, planning, execution, monitoring, reporting and approval.
• Assist change control activities throughout production.
• Maintain robust production processes such as CTX cascading, monitoring tools, and PFMEA activities to reduce human error.
• Lead non‑conformance and CAPA investigations.
• Drive improvement plans with suppliers and contribute to production stabilization, trend analysis, and process improvements.

Required profile

• BSc or Practical Engineer degree in Engineering, Quality Assurance or related field; CQE certification is a plus.
• Practical knowledge of ISO 13485 and experience in medical device electromechanical manufacturing.
• Demonstrated ability to work with suppliers and manage product lifecycle quality.

Required skills

• ISO 13485 compliance
• Process validation
• PFMEA (Process Failure Mode Effects Analysis)
• CAPA (Corrective and Preventive Action) management
• Change control procedures