Software QA

The Senior Software QA will be responsible for designing, developing, and executing software testing, based on a set of specified user and system requirements.

Responsibilities

  • Generate test plans and scenarios for software modules and their associated interfaces based on functional and system requirements

  • Define and execute test cases for integration and system testing

  • Document, classify and resolve defects

  • Support development efforts by aiding with testing and troubleshooting

  • Assist in development of requirements (design inputs) and ensuring testability of requirements

  • Ensure compliance of test documentation with QMS and regulatory requirements

  • Write engineering and/or project documentation, including generation of regulatory submissions such as FDA 510(k)

  • Maintain and enhance the test automation framework through continued evaluation of test cases for inclusion in regression, automation for newly integrated features, and development of toolsets to augment QA and development testing

On the non-technical side:

  • Participate in routine scrum meetings

  • Participate in documentation reviews

  • Work closely with other Software team members and the QA team to ensure quality and punctual software development

  • Work closely with the QA and Applications teams to ensure clear and accurate help and training documentation pertaining to developed software

  • Observe clinical uses of the software and identify areas of improvement and new avenues of development

Requirements

Education/Certifications

  • Bachelor’s degree in Computer Science, Computer Engineering, or equivalent

Skills

  • An understanding the complexity of implementing agile development practices in a software development environment where there is a need to meet regulatory requirements

  • Able to demonstrate software testing & development skills

  • Working knowledge of software application design, development, and testing

  • Self-motivated and self-managing

  • Attention to detail

  • Able to work both independently and on a team

  • Able to successfully work under tight project deadlines

  • Able to communicate clearly and effectively

Experience

  • 3 plus years of software QA experience

  • Medical industry or other regulated industry experience

  • Hands on knowledge of source control systems and GIT in particular

  • Experience with test automation frameworks & products, and requirements and test management tools such as JIRA

  • Experience with the DICOM Standard in medical imaging

  • Experience with medical software development under FDA, EU GMP, and ISO 13485

  • Familiarity with the IEC 62304 development methodology