Quality Engineer: Regulated Software for AI Healthcare

Sword; Portugal; Remote; EUR 55,000 - 85,000; Full time

Job summary

Sword is seeking a Software Quality/QA professional to ensure software is developed, released, and maintained in compliance with regulatory standards. You will collaborate with engineering, product, and regulatory teams to embed quality into day‑to‑day delivery.

Role focuses on release management, technical documentation, and adherence to IEC 62304, ISO 13485, and ISO 14971. Strong communication and independence are essential for success in a regulated, fast‑moving healthcare AI environment.

Qualifications

• 3+ years of experience in software quality, QA, or a regulated environment.
• Hands-on experience with release management and technical documentation.
• Familiarity with quality management systems and regulated software.
• Understanding of the software development lifecycle and CI/CD concepts.
• Strong attention to detail and clear written communication.
• Ability to work independently and collaborate across teams.

Responsibilities

• Manage and coordinate software releases, including release readiness checks, approvals, and release records
• Create and maintain technical documentation (e.g., software requirements, verification and validation records, traceability matrices, risk files)
• Support software lifecycle processes in line with standards such as IEC 62304 and ISO 13485
• Review change requests, bug reports, and deviations, and assess their quality and regulatory impact
• Contribute to risk management activities (ISO 14971)
• Support internal and external audits, CAPAs, and process improvements
• Promote quality best practices within development teams

Skills

Release management

Documentation

Quality assurance

Regulated environment

Tools

CI/CD

Job description

Sword is seeking a Software Quality/QA professional to ensure software is developed, released, and maintained in compliance with regulatory standards. You will collaborate with engineering, product, and regulatory teams to embed quality into day‑to‑day delivery.

Role focuses on release management, technical documentation, and adherence to IEC 62304, ISO 13485, and ISO 14971. Strong communication and independence are essential for success in a regulated, fast‑moving healthcare AI environment.