Software Validation QA Engineer – GAMP5 & ISO 13485

Jobtailor

Cambridge

On-site

GBP 40,000 - 60,000

Full time

14 days+

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Job summary

Qureight in Cambridge is seeking a Software Test Engineer to help implement testing strategies across its integrated software stack, including automated unit, integration, regression and E2E tests. You will validate regulatory, privacy and security requirements prior to release, manage test runs and report defects, participate in design reviews and contribute to automated artefacts.

This role emphasizes quality assurance within a ISO 13485 and GxP/GAMP 5 context, with a focus on continuous

Qualifications

  • Industry experience in software testing for a cloud-hosted product suite.
  • Experience validating Python-based software stacks; ML components advantageous.
  • Skilled in common test frameworks and CI/CD tools (pytest, Playwright, Selenium, Gitlab).
  • Excellent problem-solving, analytical mindset and strong communication skills.
  • Bonus: experience in software validation in regulated industries (ISO 13485, GxP, GAMP 5).
  • Knowledge of computer systems validation methodologies (GAMP 5).
  • Degree in computer science or engineering beneficial but not essential.

Responsibilities

  • Help implement testing strategies across the software stack (unit, integration, regression, E2E).
  • Ensure functional, performance, regulatory, privacy and security requirements are tested before release.
  • Manage test runs; report and track software defects.
  • Participate in software design reviews to ensure testable requirements.
  • Contribute to automated artefacts and process improvements.
  • Attend sprint planning and stand-up meetings to stay aligned with development.
  • Support CSV efforts across multiple platforms to ensure compliance with regulatory standards.
  • Suggest improvements to quality and ways of working.
  • Stay up to date with best practices and testing frameworks.

Education

Degree or degree-equivalent in a relevant scientific or technical area (beneficial)

Tools

pytest
Playwright
Selenium
Gitlab

Job description

Qureight in Cambridge is seeking a Software Test Engineer to help implement testing strategies across its integrated software stack, including automated unit, integration, regression and E2E tests. You will validate regulatory, privacy and security requirements prior to release, manage test runs and report defects, participate in design reviews and contribute to automated artefacts.

This role emphasizes quality assurance within a ISO 13485 and GxP/GAMP 5 context, with a focus on continuous

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