Write, execute, and update test protocols in accordance with SOPs.
Record, report, and verify software defects to accurately depict the software requirements also work closely with Software Engineering team toward the reporting and resolution of design issues and/or software defects
Create change orders in document control system. Conduct test design reviews and risk assessments with core team members, Influences key stakeholders to drive quality improvements.
Participate in Validation to ensure the software meets user needs requirements of user workflows for a regulated environment
Create and update validation deliverables, provide and analyze test data to drafts of validation report. Generate and update traceability matrices and quality metrics
Analyze problems as they occur and recommend potential solutions using software quality, regulatory compliance knowledge and by using DBS tools (where applicable)
Builds knowledge of the company processes and customers
The essential requirements of the job include
BA/BS degree or equivalent work experience in Computer Science, Biology, BioMedical or related field.
5+ years of software testing experience in a regulated environment.
Understanding of FDA and ISO regulations, e.g., design controls, risk management, and software validation.
Experience with: Windows environments, Web application testing, and working knowledge of SQL, including the ability to run queries, and interpret results.
Self-motivated, willing to learn new concepts, technologies, and products quickly. Excellent interpersonal, writing and communication skills, troubleshooting skills and passionate about testing, product quality, and customer satisfaction.
Able to train and help colleagues with less experience; be able to lead small and projects with manageable risks and resource requirements
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