Software Engineer QA/RA

About Us
We are a cutting-edge company specializing in AI/ML-enabled software medical devices that support the development of personalized cancer vaccines and solutions for infectious diseases. Our mission is to leverage advanced technologies in bioinformatics, immunology, and data science to deliver life-saving treatments and innovations.

We are currently seeking a motivated and skilled Software Engineer QA/RA) to join our Quality Assurance & Regulatory Affairs team. You will play a key role in ensuring the compliance and quality of our AI/ML-enabled software, focusing on automation of documentation and traceability tasks, as well as collaborating with cross-functional teams to support our product's lifecycle.

Key Responsibilities
Documentation Automation:
Develop, maintain, and enhance automation tools to streamline quality and regulatory documentation processes using platforms such as GitHub, Jira, and Confluence. Assist in the creation, review, and maintenance of key software development lifecycle SDLC) documentation, such as risk management reports, traceability matrices, and technical documentation.

Quality Assurance Support:
Assist in the development and execution of software verification and validation protocols to ensure product quality and compliance with medical device standards (e.g., IEC 62304.

Regulatory Affairs Collaboration:
Work closely with the QA/RA manager and other stakeholders to support the regulatory submissions of AI/ML-enabled SaMD, ensuring compliance with FDA, EMA, and other relevant global regulatory requirements.

Software Lifecycle Management:
Ensuring clean, maintainable, and efficient code while adhering to best practices in software engineering. Implement and manage CI/CD pipelines using GitHub Actions to ensure code quality and automated testing. Document code and workflows using Markdown and reStructuredText for internal teams and open-source communities. Participate in code reviews and ensure adherence to coding standards and best practices.

AI/ML Model Compliance:
Collaborate with data science teams to ensure the quality and regulatory compliance of AI/ML models used in the product. Assist with testing, validation, and documentation of models as required.

Risk Management:
Participate in risk assessment activities (e.g., FMEA and contribute to the mitigation of identified risks related to software functions and data integrity.

Traceability and Impact Analysis:
Contribute to creating traceability between requirements, design, implementation, testing, and post-market surveillance data to ensure complete visibility throughout the product lifecycle.

Process Improvement:
Support continuous process improvement initiatives for QA and RA activities, identifying areas for automation or optimization to reduce manual work and increase operational efficiency.

Requirements
Educational Background:
Bachelorʼs or Masterʼs degree in Software Engineering or Computer Science.

Experience:

• 2+ years of experience in software development, quality assurance, or regulatory affairs for software medical devices SaMD.

• Hands-on experience with AI/ML-enabled software or knowledge of machine learning concepts in a regulated environment is a strong plus.

Technical Skills:

• Experience in software development, with a focus on automation.

• Experience in Python and containerization technologies.

• Experienced with version control systems, particularly Git.

• Demonstrated experience in automating documentation workflows and ensuring regulatory compliance throughout the software lifecycle.

• Hands-on experience with continuous integration CI tools and implementing CI/CD pipelines.

• Demonstrated experience with Markdown and reStructuredText or LaTeX or similar

• Excellent written and verbal communication skills in English, the working language of the company.

Soft Skills:

• Excellent communication and collaboration skills to work with cross-functional teams including biologists, bioinformaticians, and data scientists to integrate software solutions with scientific research tools.

• Attention to detail and ability to work in a regulated environment.

• Problem-solving mindset with a proactive approach to identifying and addressing issues.

Nice to Have:

• Experience with cloud platforms (e.g., GCP).

• Familiarity with regulatory standards for software medical devices (ISO 13485, IEC 62304, FDA 21 CFR Part 820, etc.).

• Experience with software verification and validation processes.

• Understanding of risk management principles (ISO 14971 and quality management systems.

• Knowledge of bioinformatics, immunology, or personalized medicine.

What We Offer

• An exciting working environment at the forefront of AI-driven, personalized cancer immunotherapy and infectious disease research.

• A highly diverse and interdisciplinary team.

• A personal budget for work-related items.

• A learning budget that you can spend on conferences to stay up to date on the latest developments in the field, as well as expand your knowledge.

• Flexible working hours in a hybrid work environment.

• Social and team-building activities.

• Negotiable salary based on your level of experience.

• Responsibility and possibilities for further professional development.

• Excellent pension benefits.

• Treatment insurance.

• Days off between Christmas and new years.