Quality Engineer

We are looking for a Quality Engineer who is passionate about advancing healthcare through technology.

In this role, you will ensure that AI-driven medical software solutions meet the highest standards of quality, reliability, and regulatory compliance.

Key Responsibilities:

• Oversee and implement quality assurance activities throughout the entire software medical device lifecycle, ensuring that all procedures and standard operating processes comply with regulatory expectations.
• Verify software quality and conformance to design and technical specifications, maintaining detailed traceability and risk documentation for each component.
• Collaborate in defining, reviewing, and validating user requirements and design specifications to confirm that they are measurable and testable.
• Partner with product management to design comprehensive test strategies covering usability, performance, security, functionality, and reliability.
• Participate in troubleshooting and root cause analysis for issues encountered during development, testing, or post-market use.
• Contribute to improving the software development lifecycle by integrating best practices for AI/ML validation and software security.
• Identify and execute opportunities to optimize processes, strengthen long-term compliance, and improve product quality.
• Lead the validation of non-product software tools used within the organization.
• Work closely with Regulatory Affairs to maintain alignment with FDA, EMA, and other applicable standards and regulations.

Your Profile:

• A bachelor’s degree in Systems Engineering, Computer Science, Biomedical Engineering, or a closely related discipline.
• Proven experience in quality engineering within a regulated environment, ideally in the medical device or healthcare technology sector.
• Alternatively, 3–5 years of experience in software quality, development, or validation roles - or equivalent education and experience.
• Familiarity with standards such as IEC 62304, IEC 82304, and ISO 14971.
• Strong grasp of validation and testing processes for both medical device software and internal-use software tools.
• Demonstrated experience in producing and maintaining thorough documentation of test cases, results, and validation activities.
• Excellent communication skills in English, both written and spoken.
• Practical experience with project management and development tools such as Jira, Confluence, Xray, Python, GitHub, or Google Cloud Platform.
• Comprehensive knowledge of testing methodologies, including unit, functional, regression, integration, performance, white-box, and black-box testing.

What We Offer:

• A dynamic work environment at the forefront of AI innovation in cancer and infectious disease research.
• A diverse and interdisciplinary team of international professionals.
• Competitive compensation based on experience and expertise.
• Opportunities for continued professional growth and scientific contribution, including publications in leading journals and conferences.
• Flexible work arrangements with a hybrid schedule.
• Engaging social events and team activities.
• A meaningful career that contributes directly to improving patient outcomes and public health.

For any questions, contact Lucy on [email protected]