Validation Engineer

Exp: 5+ years**Key Responsibilities**- Review **Software Requirements Specification (SRS)** and **Software Design Specification (SDS)** for testability.
- Develop **Verification Test Plans**, **Test Protocols**, and **Test Cases** following IEC *****.
- Create and maintain **traceability matrices** linking:- Requirements Test Cases Test Results.Execute:- Functional testing- Integration testing- Regression testing- Interface testing (e.g., sensors, actuators)- Perform **risk‐based testing** aligned with ISO ***** hazard controls.
- Document **objective evidence** of verification activities for regulatory submission.
- Log, investigate, and track defects using the organization's QMS.Ensure compliance with:- FDA 21 CFR ****** (Design Controls)- IEC ***** (Software Life Cycle)- IEC *******/IEC ********* (Usability considerations)- Support audits and provide documentation to regulatory bodies (FDA, NB, internal QA).
MXW3G

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