- Company Name
- Abacus Service Corporation
- Job Title
- Software Tester & Validation Specialist - Regulatory
- Job Description
-
Job title: Software Tester & Validation Specialist – Regulatory
Role Summary:
Lead verification and validation activities for ultra‑widefield retinal imaging system software, ensuring safety, effectiveness, and regulatory compliance through structured test programs, risk‑based testing, and formal documentation aligned with a Quality Management System.
Expactations:
• 6‑month contract role; emphasis on high‑reliability, medical‑device‑regulated testing.
• Collaborate with Software Engineering, Systems/Hardware, Clinical/Applications, and Quality/Regulatory teams.
• Deliver test strategy, plans, cases, and reports; maintain regression suite.
Key Responsibilities:
- Own end‑to‑end test strategy for releases, patches, hotfixes, and feature updates.
- Create and maintain Test Plans, Test Protocols, Test Cases (functional, regression, integration, end‑to‑end clinical workflows), and Test Summaries.
- Execute manual testing; support and develop automated tests (UI, API, system regression).
- Build a continuous regression suite covering core imaging workflows and device stability.
- Validate software behavior across all supported configurations (OS, device builds, camera/sensor variants, peripherals, compute variants).
- Ensure comprehensive coverage of clinical processes: patient entry, acquisition, review, export, connectivity, error handling, rework, and recovery states.
Required Skills:
- Minimum 1+ year of software testing/QA experience, preferably in regulated or high‑reliability (medical device) environments.
- Proficient in writing test plans, test cases, test reports, and validation protocols.
- Solid understanding of SDLC, agile practices, defect management, risk‑based testing principles, and hardware/software integration.
- Strong communication skills with ability to translate technical findings into actionable outcomes.
- Familiar with requirement and test management tools (Jira, Azure DevOps, TestRail, Zephyr, Confluence).
Required Education & Certifications:
- Bachelor’s degree in Computer Science, Software Engineering, Biomedical Engineering, or related field (or equivalent experience).
- Certifications in medical device quality/validation (e.g., ISO 13485, IEC 62304) are an advantage.
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