| Job D Primary Skills:
* In-depth knowledge and practical experience with SaMD testing principles, software validation (IQ, OQ, PQ), risk-based testing, and relevant regulatory standards (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304).
* Proficiency in Manual Testing techniques, test case design (e.g., boundary value analysis, equivalence partitioning), and exploratory testing.
* Strong hands-on experience in developing test automation scripts and frameworks using JavaScript.
* Expertise in using Puppeteer and Mocha for automating web-based application testing.
* Proven experience integrating test automation into Azure DevOps CI/CD pipelines.
* Expertise in using Jira for defect tracking, project management workflows, and reporting.
* Experience with Jama for requirements management and demonstrating end-to-end traceability from requirements to test cases and defects.
Medical devices experience is mandatory (radiation / oncology treatment would be added advantage)
Good to have: SaMD domain experience
Secondary Skills:
Understanding of Radiation Therapy QA workflows, clinical user needs, and domain-specific terminology.
Experience with other types of testing such as performance, security, usability, or compatibility testing relevant to medical devices.
Proficiency in using Zephyr for detailed test case management, execution tracking, and reporting.
Experience with other test automation frameworks or tools.
Knowledge of other programming languages (e.g., C#).
Experience working in a strict Agile/Scrum development environment within a regulated industry.
Relevant certifications (e.g., ISTQB Advanced Level, ASQ certifications).
Familiarity with static analysis or code inspection tools. |
Cognizant North America
May 17, 2025 