Quality Assurance Engineer

About Us

We are a leading global medical device company specializing in ECG technology. With 30 years of experience, we're at the forefront of innovation in cardiac monitoring solutions. Our products are used worldwide, making a significant impact on patient care and cardiac diagnostics.

Position Overview

We're seeking a detail-oriented and skilled QA Engineer to join our team in Yokneam, Israel. The ideal candidate will play a crucial role in ensuring the quality and compliance of our medical devices throughout the product lifecycle.

Responsibilities

• Update production files, technical documents, procedures, and forms
• Conduct quality control during production processes
• Perform final QA tests before product shipment
• Manage corrective and preventive actions (CAPA)
• Prepare Certificates of Compliance (C.O.C)
• Oversee calibration processes
• Handle non-conforming products through Material Review Board (MRB)
• Conduct internal and external audits
• Collect and analyze statistical data for management review
• Process and analyze customer feedback and complaints
• Manage ESD (Electrostatic Discharge) and environmental controls
• Perform facility maintenance inspections
• Review and approve design documents (DHF)
• Plan and report on training activities
• Collect data on service and installation processes
• Handle supplier complaints and conduct annual supplier evaluations

Requirements

• Bachelor's degree in Engineering, preferably in Biomedical, Electrical, or related field
• Minimum 3-5 years of experience in QA within the medical device industry
• Fluent English, both spoken and written