Quality Engineer

A stable and well-established global medical device company is looking for an experienced Quality Engineer to join its Quality team.

This role offers a hybrid work model and the opportunity to be part of a leading medical device environment, working on complex, cutting-edge technologies and contributing throughout the entire product lifecycle within a stable, global organization.

Responsibilities:

• Lead investigations of quality issues, customer complaints, and non-conformities.
• Perform root cause analysis and drive effective corrective and preventive actions (CAPA).
• Monitor, track, and ensure timely implementation and closure of CAPA activities.
• Support and maintain compliance with quality management systems and regulatory requirements.
• Participate in Design Reviews and quality activities throughout the product development lifecycle.
• Work closely with R&D, Manufacturing, Regulatory Affairs, and other cross-functional teams.
• Support risk management activities and quality improvement initiatives.
• Analyze quality trends and recommend process and product improvements.
• Ensure compliance with medical device regulations and standards, including FDA, CE, and ISO 13485

Requirements

• Bachelor's degree in Engineering, Life Sciences, or a related field (Master's degree is an advantage).
• At least 2 years of experience as a Quality Engineer in the medical device industry – mandatory.
• Proven experience supporting R&D/Product Development Quality activities – mandatory.
• Experience participating in Design Reviews and familiarity with Design Control processes.
• Strong knowledge of quality systems and regulatory requirements, including ISO 13485, CE, and FDA.
• Understanding of manufacturing processes, quality control methodologies, and statistical tools.
• Experience conducting root cause analysis, risk assessments, and CAPA management.
• Strong analytical, organizational, and problem-solving skills.
• Excellent communication and teamwork abilities.
• Fluent Hebrew and English, both written and spoken.