Quality Assurance Engineer

Who we are

We are here to improve lives by restoring sight worldwide by a robotic platform for vision saving surgery. Our company will improve the way ophthalmic surgery is delivered to vision impaired individuals now and for decades to come.

We are rapidly growing, funded by leading international VCs, and are looking to expand our small, motivated, multi-disciplinary and phenomenal team. Joining us is an opportunity to work towards saving vision across the globe, collaborating with others to realize a dream, and tackle an enormous challenge that will help drive your career forward.

Who we are looking for

We are looking for an experienced Quality Assurance Engineer to support the implementation, maintenance, and continuous improvement of the Quality Management System (QMS), ensuring compliance with applicable regulatory requirements, company procedures, and quality standards. The QA Engineer will contribute to quality activities throughout the product lifecycle, drive continuous improvement initiatives, and collaborate closely with cross-functional teams to ensure product quality and regulatory compliance.

Responsibilities

• Support the implementation, maintenance, and continuous improvement of the Quality Management System (QMS).
• Participate in quality processes and activities, including document control, CAPA, nonconformance, and change management.
• Participate in internal and external audits and support regulatory inspection activities.
• Contribute to supplier quality and quality-related training activities.
• Review and approve quality records and documentation in accordance with applicable procedures and regulatory requirements.
• Collaborate with cross-functional teams to ensure compliance with internal procedures, quality standards, and regulatory requirements.

Requirements

• Bachelor’s degree in Engineering, Quality Assurance, Life Sciences, Biotechnology, or equivalent.
• CQE certification – an advantage.
• 5+ years of experience in Quality Assurance within the medical device industry.
• Hands-on experience working within a Quality Management System compliant with ISO 13485:2016 and 21 CFR Part 820 requirements, with familiarity with EU MDR requirements.
• Experience with CAPA, audits, nonconformance management, document control, and change management processes.
• Experience reviewing and approving Device History Records (DHRs) – an advantage.
• Experience supporting regulatory inspections or external audits – an advantage.
• Strong organizational and documentation skills, with the ability to work independently and collaborate effectively in cross-functional teams.
• Written, and verbal communication skills in Hebrew and English.