Requirements:
Experience in Manual testing – Medical devices
- Test Planning, Test case design, Test cases writing, Test case review and test results reviews, Defect Logging, Defect Analysis. Regression testing
- Hands on experience in SDLC/STLC process.
- Compliance Analysis, Compliance Plan document, User Requirements document, Functional Requirements document, Risk Assessment document
- System Test Protocol/ Scripts, User Acceptance Test Protocols/ Scripts, System Test Reports, User Acceptance Test Reports, Compliance Report
- Hands on experience in preparing test cases using Black box testing techniques
- Able to create Test Cases from the Functional Specifications / Software Requirement Specification document.
- Able to test the Functionality as per the Test plan and respective Test Cases.
- Good communication skills / He has to work independently with customer
- Hands on experience in leading, mentoring, assigning the work to team members and has worked in effort estimation.
- Exposure to ISO13485, 14971
- Knowledge on FDA regulations and guidelines.
- Team Interaction with Cross function stakeholders
- Technical reviews of Verification work products
- Coordination between team members
- Obtain clarifications and feedback from Customer
- Organize reviews and team meetings.
- Release deliverables and project administrative activities