Quality Assurance Engineer

ForSight Robotics

ForSight Robotics

Quality Assurance
Yokne'am Illit, Israel
Posted on Saturday, June 22, 2024

Who we are

At ForSight Robotics, we believe that sight is a basic human right. We are united behind our mission to improve global access to sight-saving surgical eye care. Through ingenuity and intelligent technology, we are enhancing surgeons’ and patients’ lives. As a pioneer and market leader in ophthalmic robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. We empower our team members to do their best work as their most authentic selves while driving forward our vision“ - For All to See ”.

Who we are looking for

Passionate people who want to make a difference drive our culture - our team members are grounded in integrity, have a strong capacity to learn, have the energy to get things done and bring diverse, real-world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

We are looking for a meticulous and proactive QA Engineer to join our dynamic QA team.

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

This is an ideal opportunity for someone who is motivated and passionate to make an 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 identification), and implement corrective actions to resolve the issue and prevent recurrence.
  • Suppliers’ management - evaluate and approve suppliers, conduct supplier audits, and monitor supplier performance. Work with suppliers to resolve quality issues and ensure the supply chain meets all quality requirements.
  • Evaluate and manage nonconforming materials and components within the organization (MRB).
  • Work with cross-functional teams to identify and implement process improvements and best practices to enhance operational quality and efficiency.
  • Collaborate with engineering team to develop and maintain process validation protocols (IQ, OQ, PQ).
  • Provide training and support to operations staff on quality assurance processes and best practices. Promote a culture of continuous improvement and quality awareness.
  • Identify areas for improvement in the manufacturing process 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. Prepare reports on quality performance and issues.
  • Analyse quality data to identify trends and areas for improvement. Use statistical tools to monitor and control quality processes.

Requirements

  • B.Sc in Quality/ Biomedical/ Biotechnology or similar from a known academic institution.
  • Certified Quality Engineer (CQE).
  • 5+ years of hands-on experience in a similar role in a multi-disciplinary 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.