📍 Location: Remote / Hybrid ⏳ Commitment: 1.0 FTE 📜 Contract: Open-ended (3-month trial period) 💰 Salary: €2,800 – €4,500 gross per month, depending on experience and qualifications
What will your day look like?
You will play a key role in ensuring that our software meets the highest quality, safety, and regulatory standards. Your work will touch every stage of our Software Development Life Cycle (SDLC):
Planning and executing test strategies for software development Designing and running test cases, documenting results, and managing defects. Maintaining traceability of requirements, risks, and mitigations. Using automation frameworks for API and UI testing within CI/CD pipelines. Collaborating with R&D and QARA teams to improve product quality and compliance. Supporting audits, CAPAs, and regulatory documentation as needed.
Key Responsibilities Lead quality assurance activities for software development in a regulated environment. Ensure compliance with internal policies and relevant standards (ISO 13485, ISO 27001, IEC 62304, IEC 82304, 21 CFR FDA Part 11 & 820). Recommend improvements in testing approaches, technologies, and processes to enhance product quality, security, and safety. Support documentation and reporting for internal and external audits.
Requirements
Mandatory: 3+ years of professional experience as a Quality Assurance Engineer in software preferable within the healthcare field, in medical devices. 2+ years experience deploying automation frameworks to create comprehensive automated tests to create comprehensive automated test cases for API and UI testing.
Desirable:
Experience in the SDLC in a regulated environment, ideally in the healthcare sector (IEC 62304, IEC 82304, ISO 13485:2016, ISO 27001, 21 CFR FDA Part 820, 21 CFR FDA Part 11).
