Company Description

Toku is a healthcare technology company based in Auckland, New Zealand. Our mission is to create a world focused on preventive healthcare by using the eye as a window to our health. We believe every person should have access to early diagnosis of health conditions. Toku develops tools using AI and retinal images to enable accessible healthcare for early and accurate diagnosis, empowering individuals to make conscious health choices.

Role Description

We seek an experienced and highly motivated Quality Assurance Manager to join our team. The successful candidate will be responsible for ensuring that our products meet the highest quality standards and comply with international regulations and standards.

Key Responsibilities:

• Maintain a comprehensive Quality Management System (QMS) in compliance with ISO 13485 and other relevant standards and regulations.
• Ensure compliance with regulations such as FDA (21 CFR Part 820, 21 CFR Part 11) and EU MDR.
• Oversee the application of risk management principles in accordance with ISO 14971.
• Ensure that all software development processes comply with IEC 62304 and usability engineering standards per IEC 62366.
• Implement and manage cybersecurity measures following relevant guidelines and ISO/IEC 27001 standards.
• Assisting in managing external audits and inspections from regulatory bodies.
• Manage the document control system, ensuring all documentation is accurate, up-to-date, and compliant with regulatory requirements.
• Develop and oversee quality assurance processes for product development, manufacturing, and post-market surveillance.
• Lead the investigation and resolution of product quality issues, including root cause analysis and corrective/preventive actions (CAPA).
• Train and mentor staff on quality assurance practices and regulatory compliance.
• Stay current with changes in regulations, standards, and industry best practices to ensure ongoing compliance.

Qualifications

• Bachelor’s degree in a relevant field (e.g., Quality Assurance, Engineering, Life Sciences).
• Minimum of 5 years of experience in quality assurance for software as a medical device within the medical device industry.
• In-depth knowledge of ISO 13485, ISO 14971, IEC 62304, IEC 62366, and ISO/IEC 27001.
• Strong understanding of FDA regulations (21 CFR Part 820, 21 CFR Part 11) and EU MDR.
• Experience with cybersecurity guidelines for medical devices is a plus.
• Proven track record of managing QMS and ensuring compliance with international standards and regulations.
• Excellent analytical, problem-solving, and decision-making skills.
• Strong communication and interpersonal skills, with the ability to train and mentor staff.
• Detail-oriented and highly organized, with the ability to manage multiple tasks and priorities.