Quality Assurance Operations 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 and proactive QA Engineer to join our dynamic team.

As a QA Engineer, you will play a key role in ensuring the quality and efficiency of our operational processes. You will be responsible for developing and executing quality assurance activities, analyzing performance data, identifying improvement opportunities, and collaborating with cross-functional teams to drive operational excellence. Your mission is to ensure our operations meet the highest standards of quality, reliability, and performance.

This is an exciting opportunity for someone motivated and passionate about making a meaningful impact in creating the next generation of ophthalmic robotic surgery.

Responsibilities

• Develop, implement, and maintain operational processes and procedures in compliance with ISO 13485, FDA 21 CFR Part 820, and other relevant standards, regulations, and company policies.
• Identify and investigate operational issues (including root cause analysis) and implement corrective and preventive actions to resolve issues and prevent recurrence.
• Supplier management – evaluate and approve suppliers, conduct supplier audits, and monitor supplier performance and work with suppliers to resolve quality issues.
• Evaluate and manage nonconforming materials and components within the organization (MRB).
• Manage equipment calibration and maintenance programs to ensure all production and inspection equipment are properly calibrated and maintained in accordance with regulatory and internal requirements.
• Work with cross-functional teams to identify and implement process improvements and best practices to enhance operational quality and efficiency.
• Collaborate with the engineering team to develop and maintain process validation protocols a (IQ, OQ, PQ).
• Provide training and support to operations team on quality assurance processes and best practices, promoting a culture of continuous improvement and quality awareness.
• Identify opportunities for improvement in manufacturing processes to enhance product quality and efficiency.
• Conduct and oversee product testing, inspection, and validation to ensure compliance with specifications and standards.
• Maintain accurate records of quality inspections, tests, and other quality-related activities and prepare reports on quality performance and issues.
• Analyze quality data to identify trends and areas for improvement, using statistical tools to monitor and control quality processes.
• Support internal and external audits, participate in change control and risk management activities, and ensure proper documentation and environmental controls to maintain consistent operational quality.

Requirements

• Bachelor's degree in Quality, Biomedical Engineering, Biotechnology, or a related field from a recognized academic institution. Master's degree is an advantage.
• Certified Quality Engineer (CQE) - an advantage.
• 3+ years of hands-on experience in a similar role within a multidisciplinary medical device company, working according to GMP and CFR 21 Part 820, ISO 13485 regulatory requirements.
• Strong analytical and problem-solving skills.
• Ability to work independently and as part of a team.
• Strong interpersonal, written, and verbal communication skills (Hebrew & English).
• Qualified auditor – advantage.