Software Quality Assurance Director jobs in North Carolina

• Create end-to-end test plans and test scenarios.
• Execute test plans and ensure that all the requirements are met, and that the software works as expected. The software is tested in terms of functionality, performance, reliability, stability, and compatibility with other legacy- and / or external systems.
• Review functional and design specifications to ensure full understanding of individual deliverables.
• Identify test requirements from specifications, map test case requirements and design test coverage plan.
• Develop, document, and maintain functional test cases and other test artifacts like the test data, data validation, harness scripts and automated scripts.
• Execute and evaluate manual or automated test cases and report test results.
• Hold and facilitate test plan/case reviews with cross-functional team members.
• Identify any potential quality issues per defined process and escalate potential quality issues to management.
• Ensure that validated deliverables meet functional and design specifications and requirements.
• Isolate, replicate, and report defects and verify defect fixes.
• Prepare test reports and participate in assessing residual risk.
• Investigate Customer issues, collect and analyze logs, report findings and recommendations to Engineering.
• Participate in activities in Risk Management and Usability Engineering Process.
• Generate content and maintain records in a Quality Management System.

• B.S. in Software or Biomedical Engineering or related field, 4 years of experience as a Software Quality Assurance Engineer, with experience in writing clear, concise, and comprehensive test plans and test cases, with hands-on experience with both white box and black box testing, and experience with automated testing tools and frameworks.
• Experience with testing software in medical devices.
• Experience with testing medical device communication results to Laboratory Information Systems and/or Electronic Health Records Systems.
• Knowledge of communications protocols used in health data applications (e.g.: HL7, FHIR or
• related standards).
• Experience with Software Management Tools (Jira, Azure DevOps or VSTS).
• Experience with testing Azure Cloud Environments.
• Experience with using a programming or scripting language (e.g.: C# or Python) to leverage testing tasks.
• Experience with at least one Data analysis tool (e.g.: Excel or R).
• Willingness to work in a fast-paced, multidisciplinary environment.

• Experience with testing cloud-connected medical devices.
• Experience with aspects of Quality in Medical Devices (ISO 13485, ISO 14971, IEC 62304, and IEC 62366), and FDA’s 510(k) process.
• Experience with writing Automated Unit Tests in DevOps.
• Experience with the use of SQL or other database-querying languages.
• Experience with testing device-oriented services in Microsoft Azure (e.g.: Azure Functions, IoT Hub, etc.).
• Experience in IT support, with understanding of wired and wireless networking and network security.
• Knowledge of principles of Computer Software Validation for systems used in development and manufacturing of medical devices.
• Experience with testing Point-of-Care medical devices.
• Experience with testing and troubleshooting embedded and electromechanical devices and lab instrumentation.

About AAD
At AAD, we are committed to our team and customers. We believe in fostering a culture that promotes creativity, learning, and leadership. Through our efforts and values, AAD has been able to cultivate new ideas and create new technologies to revolutionize the healthcare industry. 

We welcome enthusiastic, driven professionals, passionate about positively impacting healthcare by providing relevant, valuable, and actionable information. We are devoted to creating a diverse and inclusive environment in order to best support innovation and the talents of our people. We look for people who bring diverse ideas, demonstrate integrity and show dedication to the success of our customers. We offer competitive benefits, including health, dental, and vision insurance, 401k, and paid vacation.