Job Respobsibilities:
Plan, Develop and execute software testing (both manual and automated – White/Black Box) for medical devices, based on context and risks associated with the project.
Participate in some level of basic software design reviews and documentation that establish high level of confident that the software development meets the required quality parameters.Participate in test activities, incident management and tracking – with both on or offsite test resources.
Handson experttise in writing verification and validation test protocols.
Create test reports suitable for submission to regulatory authorities to demonstrate that software is validated, and all requirements are verified.
Responsible for ensuring that the software development process follows established procedures, standards and plans. And the risk associated with the software is identified, analyzed and managed appropriately.
Participate in other quality assurance functions, including, but not limited to, supporting compliance audits, test automation strategy and development.
Active Participation in team meetings, discussions and customer meetings.
Involvement in Innovation, technical discussion’s, product/process improvements and Kaizans.
Well versed with SDLC and have understanding of Requirements Management, configuration management and defect tracking concepts.
Problems solver and effective communicator
Minimum Qualifications & Specialized Knowledge required
ME/MTech/BE/BTech in Electronics & Communication Engineering, Computer Science or relevant field.
8+ years in software quality assurance, V&V or software quality development.
Or, some medical device product experience (preferably electro-mechanical medical device) or regulated fields.
At least 5 years Working experience in SWQA of ‘System Sofware Testing’.
Some working experience in a prescriptive software development environment following a well-defined software development process.
Understand test automation concept, and scripting languages (e.g. Python, Perl, etc.)
Excellent verbal and written communication skills and works well in a tightly coupled team
Nice to Haves
Membership in one or more professional societies and/or professional certification (e.g. CSQE, CSTE, etc.).
Familiarity with FDA regulations and recommended practices regarding software (21CFR 820.30, IEC 62304:2015, ISO 14971:2012).
Exposure to automation testing.
Experience with test equipment such as oscilloscopes, serial port analyzers, multi-meters and general lab measurement equipment.
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