The SQA Test Engineer will be responsible for facilitating testing procedures of Software-as-a-Medical-Devices (SaMD) at Cognoa. Reporting to the Director of Quality Assurance, the SQA Test Engineer will work directly with developers to assure that requirements are met and that bugs or defects are fixed before software is deployed. The SQA Test Engineer must have knowledge of quality requirements for medical devices, software-as-a-medical device, and be well-versed in 21 CFR 820, ISO 13485, and software quality assurance.
• Contribute to comprehensive test strategies/plans for SaMD, running on Android, iOS as well as web interface
• Evangelize test automation to scale testing efforts across multiple products and build automation testing functionality for diverse SW components.
• Contribute to the design, enhancement and maintenance of detailed test cases and conduct hands-on testing, including integration testing
• Provide accurate planning, clear strategies, and milestones for testing leading to successful implementation and timely project completion
• Report, track and escalate anomalies discovered during testing and ensure closure on issues, prioritizing severe defects to make sure that quality is maintained.
• Participate in release coordination and system deployment after appropriate verification,
• Record testing activities and results in Company’s Application Life Cycle Management tool in a manner consistent with regulatory requirements
• Review Design History File (DHF) documents for completeness
• Collaborate with cross-functional teams to ensure timely and robust execution of testing
• Assist with defining and implementing software quality improvement initiatives
• ability to understand system architecture, design, implementation and succinctly develop test approach and test cases to deliver high-quality results
• ability to work proactively, independently and as part of a team on multiple tasks and projects, in a fast paced and highly technical environment.
In addition, you bring
• 5 years of hands-on SQA experience in the medical device industry
• Very good knowledge of programming and scripting
• Languages such as Java, Swift, Ruby and Python
• Experience using Matrix Requirements, GitHub and working in an Agile/Scrum-like environment
• Experience in working in a regulated environment (CLIA, HIPAA, and FDA)
• Familiarity with IEC 62304
• Excellent organizational, problem-solving, and people skills
• Excellent written and verbal communication skills
• B.S or higher degree in Computer Science, Engineering, Bioinformatics, or a related study or equivalent project experience