Senior Quality Engineer for Medical Devices

3 weeks ago


London, Greater London, United Kingdom F. Hoffmann-La Roche Gruppe Full time

The Role

We are seeking a highly skilled Principal Instrumentation Software Test Engineer to lead the development and implementation of comprehensive testing strategies for our advanced medical devices. This role requires a strong background in software testing, quality assurance, and problem-solving in complex systems.

Key Responsibilities:

  1. Test Planning & Execution: Develop detailed software testing plans and scripts based on product specifications, incorporating advanced testing methodologies (e.g., regression, functional, integration, and system testing). Conduct hands-on testing, including validation and performance testing, to ensure compliance with design and regulatory standards.
  2. Complex Problem Solving: Facilitate technical problem-solving and troubleshooting for software and instrumentation challenges. Lead root cause analysis and provide engineering solutions, making independent decisions on critical issues.
  3. Project Leadership & Cross-functional Collaboration: Lead or participate in cross-functional technical teams, collaborating closely with Software, Customer Technical Support, Service, and other departments to deliver high-quality instrumentation systems that align with Roche's product portfolio and strategic objectives.
  4. Data Analysis & Insight Generation: Design and conduct experiments to validate hypotheses, analyze technical data, and provide actionable insights for product improvement.
  5. Documentation & Compliance: Ensure detailed and organized documentation for all testing activities, adhering to GLP, GMP, and regulatory standards. Lead configuration control, maintain secure documentation, and support quality-first initiatives in compliance with industry and company standards.
  6. Experience: Significant experience as a Software Test Engineer, preferably in a regulated industry such as medical devices, with expertise in testing and validation, quality assurance, and problem-solving in complex systems.
  7. Technical Skills: Proficient in a wide array of testing techniques (e.g., system, regression, integration, load testing) and software testing tools such as DevTrack and TestLink. Expert knowledge in SW planning, integration, and configuration management.
  8. Personal Qualities: Analytical, diligent, and proactive. Strong communication skills to present complex technical data effectively. Adaptable to a fast-paced environment with a focus on quality and continuous learning.

About the Company

F. Hoffmann-La Roche Ltd is a global leader in the pharmaceuticals and diagnostics industries. We are committed to making a positive impact on people's lives through our innovative products, services, and solutions.



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