In this role, you will have the opportunity to:
Perform duties as an individual contributor and/or team member with 100% hands-on work.
Participate in the submission, execution, and review of test protocols in accordance with SOPs
Record, report, and verify software defects to accurately depict the software requirements.
Participate in test protocol updates and test design reviews
Work closely with Software Engineering team toward the reporting and resolution of design issues and/or software defects
Participate in Validation to ensure the software meets user needs requirements of user workflows for a regulated environment.
Provide test data to drafts of validation report, update traceability matrices and quality metrics.
Create change orders in document control system.
Participate in daily management using DBS tools.
The essential requirements of the job include,
BE/BS degree or equivalent work experience in Computer Science, Biology, BioMedical or related field.
2+ years of Computer System Validation/ Product Software Validation 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.
Excellent interpersonal, writing and communication skills, and troubleshooting skills and passionate about testing, product quality, and customer satisfaction.
Self-motivated, willing to learn new concepts, technologies, and products quickly.
Passionate about testing, product quality, and customer satisfaction.
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