Job Title: Quality Engineer
Location: Yokneam, Israel
Job Summary: Quality Engineer, you will play a crucial role in ensuring the quality and compliance of our medical devices. You will be responsible for managing Corrective and Preventive Actions (CAPA) and Non-Conformance (NC) processes to identify, investigate, and resolve quality issues. Your work will involve collaborating with cross-functional teams to implement effective solutions and maintain regulatory compliance.
Key Responsibilities:
Conduct thorough investigations into quality issues, utilizing tools such as root cause analysis, failure mode and effects analysis (FMEA), and statistical analysis.
Collaborate with project teams to lead NC/CAPA processes, identify root causes of non-conformances, and implement corrective actions to prevent recurrence.
Drive a culture of continuous improvement within the Quality group.
Work closely with other departments such as manufacturing, engineering, R&D, and quality assurance to implement NC/CAPA solutions in a timely manner.
Ensure NC/CAPA processes comply with relevant regulatory requirements (e.g., FDA, ISO 13485).
Maintain detailed records of NC/CAPA activities, including investigation reports, action plans, and verification of effectiveness.
Analyze data to ensure the site meets necessary CAPA and NCEP metrics.
Monitor CAPA implementation aging and identify opportunities for site improvement.
Support other Quality System processes at the site, such as internal audits, external audits by Notified Bodies, quality management review, document control, etc., as assigned and where qualified.
Required Qualifications:
Bachelor's degree in engineering, quality management, or a related field.
2-3 experience in quality assurance within the medical device industry.
English fluency including writing and speaking.
