Quality Assurance Manager

About Imagene AI

Imagene AI is leading a breakthrough in AI-based cancer testing, making personalized medicine more accessible. Our mission at Imagene AI is to assist cancer patients in receiving the optimal treatment by leveraging AI to detect, in real-time, a broad range of cancerous biomarkers and genomic insights, from the biopsy image alone!

By doing so, Imagene AI overcomes economic, logistical, and technological barriers to reach the full potential of precision medicine.

Through collaborations with top-tier medical centers and pharmaceutical companies, Imagene AI is revolutionizing molecular screening for both clinical practice and research.

Our success derives from our cutting-edge technology and talented multidisciplinary team of data scientists, biologists, software engineers, and medical experts.

About the position

Imagene is seeking a skilled, thorough, strategic thinker and highly motivated Head of Quality Assurance to be responsible for leading the development, implementation, and management of quality assurance within the company. This role will ensure the company's adherence to regulatory requirements, industry standards, and internal quality policies, providing oversight and direction to drive continuous improvement.

Responsibilities

• Quality Assurance Oversight: Developing and implementing quality assurance strategies, procedures, and standards to ensure product and service excellence. This involves ensuring that the products meet certain thresholds of quality and are reliable.
• Oversee the development and maintenance of QA documentation, including test plans, quality manuals, and procedure documents.
• Risk Management: Identifying, evaluating, and mitigating compliance risks through continuous monitoring, assessments, and internal audits. This is about managing potential risks related to product quality and compliance.
• Compliance Monitoring: Regularly reviewing and monitoring company activities to ensure adherence to laws and regulations, and addressing any issues or violations promptly. This is a part of ensuring the company's operations and products are compliant with quality standards.

Requirements

• 6 years background in a similar position with solid experience in SaMD
• Proficient in regulatory and technical writing
• Bachelor's degree in Life Sciences, Engineering, or related field. Advanced degree or relevant certifications (e.g., RAC, CQA) preferred.
• A bachelor’s degree in a scientific discipline is required. M.Sc. or PhD - an advantage.
• Strong knowledge of QA methodologies, tools, and processes.
• Using critical thinking, reasoning, problem-solving and communication skills
• Self-motivated and proactive
• Previous experience with AI-based submissions - an advantage
• Experience in international companies – an advantage
• Fluent in English with excellent writing skills