About this job
Responsibilities:
Participate in creating MRS, BRS by analysing the requirements.
- Conduct review of user requirements and needs for new software and performs analysis, design, implementation, installation, and training related new software developed and/or acquired.
- Prepare master verification Plan based on DCR, SRS, DMR, UID, Design Document, RMM etc.
- Develop validation [System Level] test cases based on MRS and Verification [Sub system level] test cases based on BRS requirements; Environment test cases based on UID document.
- Participate in the DMR output form based on DCR assessments on regular basis.
- Participate in Preparation of all kinds of traceability’s [Test Environment Traceability, Requirement traceability etc] to ensure the 100% coverage.
- Prepare the exploratory test specifications for informal testing.
- Prepare the test environments suitable for informal and formal testing [system preparation, VM’s and Citrix enlivenments etc.
- Use management tools like Quality Center, Clear Quest, Req pro for controlling documents and versioning.
- Prepare the verification and validation reports during the informal and formal phases to keep track of engineering and product issues.
- Use several clinical automation tools for the testing like calibration phantoms, water and glass phantoms, DICOM Edit, DICOM Compare, PACS
- Conduct regular internal audits and make sure all documentation and evidence without any deviation.
Participate in external audits from the organization for ISO 9001:2015, ISO 13485, FDA, Bsi, IEC 62304, DEKRA etc
Academic Qualifications:
- This position requires, at a minimum, a Bachelor’s degree in Computer Science, Computer Information Systems, Information Technology, or a combination of education and experience equating to the U.S. equivalent of a Bachelor’s degree in one of the aforementioned subjects.