Job Description & Skill Requirement:
- Solid experience coding Python scripts for verification & validation of software applications in an FDA environment
- 7+ years’ experience in software quality engineering & testing in the medical device industry
- Experience writing test plans and test reports, and planning and writing effective test cases
- Solid understanding of and experience with different types of testing methods, such as functional, system, integration, User Interface (UI), usability, performance, negative scenario, and others as needed
- Extensive knowledge of FDA and ISO regulations and standards required
- Familiarity with defect tracking software and test management tools
Qualification: