Lead QA Engineer – Medical Device Embedded Software Testing

Lead QA Engineer
- Medical Device Embedded Software Testing

Up to £660/day | Inside IR35 | Hybrid
- Motherwell, Scotland

Previous hands-on experience testing embedded software within medical devices is essential. We can only consider candidates who meet this requirement.

This is a specialist device-software testing contract. General web/application QA, pharmaceutical Computer Systems Validation (CSV), manufacturing validation or quality management experience alone will not meet the brief.

You’ll lead and execute software testing for a standalone medical device used for diagnostics and patient monitoring, delivering V&V evidence for an FDA 510(k) submission and a subsequent commercial software release.

• Within an hour of Motherwell: 2 days per week onsite.
• Further away: 2-3 days per month onsite may be agreed for the right candidate.

• Rate: Up to £663/day, Inside IR35
• Start: 1 October
• Duration: 3 months initially, with a further period of at least 12 months anticipated

• Write and execute test cases against embedded medical-device software.
• Produce documented verification and validation evidence.
• Report, investigate and manage software defects through to resolution.
• Contribute to impact analysis, risk analysis and FMEAs.
• Manage testing priorities using Jira sprint boards.
• Support regulatory submission and commercial release deadlines.

• Personally writing and executing tests for software embedded within a medical device.
• Medical-device software V&V within a regulated development environment.
• Documenting test results and linking evidence to requirements.
• Risk-based testing and contribution to risk-management activities.
• Leading testing activities while remaining hands-on.

Experience supporting an FDA 510(k) submission is highly desirable.