Ligence is a fast growing company working on the forefront of cardiovascular diagnostics. Our AI-powered software automates the review of echocardiography studies - transforming how cardiology is practiced. We’re not just building products; our aim is to make a lasting impact in the history of medicine.

To help us ensure the highest quality of our software and meet regulatory standards globally, we are looking for a Quality Assurance Engineer (QAE) to join our team.

📍 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 Ligence 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 medical software within the healthcare field, preferably with experience in medical devices.
• 2+ years of experience leveraging automation frameworks to design and build comprehensive automated test suites for API and UI validation.

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).