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 creating and updating of test protocols, 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 design reviews and 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 software validation testing experience in a regulated environment.
Understanding of FDA and ISO regulations, e.g., design controls and risk management
Excellent interpersonal, writing and communication skills, and troubleshooting skills and passionate about testing, product quality, and customer satisfaction.
Experience with: Windows environments, Web application testing, and working knowledge of SQL, including the ability to run queries, and interpret results.
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