The Software Quality Engineer will be responsible for development and implementation of test plans and protocols to verify and validate Siemens Healthineers non-product software tools. The position will work closely with project management, quality assurance, statistical affairs, and information technology.
Responsibilities of the position include:
Collect and review user requirements for non-product software tools. Assist project teams with definition of user requirements in order to successfully create test plans and test protocols.
Ensure software tools are design in compliance to 21 CFR Part 11 requirements, where applicable.
Develop test plans and design test cases to evaluate software tool performance and design relative to user requirements.
Support execution of test plans and test cases, as required. Evaluate and summarize outcomes of test plan and test cases within test report.
Identify anomalies and defects, assess root cause, resolve testing issues, and drive issues to closure.
Identify any potential quality issues and escalate immediately to project team.
At least 5 years experience within software quality assurance, software engineering, informatics, or relevant experience within software development and validation.
Experience working within an FDA-regulated environment (Pharmaceuticals, Medical Device) is preferred.
Knowledge of SQL, QlikView, SAS Visual Analytics, SAS Enterprise Guide, and SAS Data Integration Studio are required. Consideration will be provided to candidates with experience with other Dashboard environments (e.g. Tableau) and SAS programming.
Experience with Relational Database Systems (e.g. Oracle, TeraData) as Database Developer or Administrator and Informatics is desired.