Software Quality Engineer

at  Vital Biosciences Inc

Do you have a passion for ensuring software meets the highest standards? As a Software Quality Engineer, you’ll play a crucial role in safeguarding the integrity and performance of our software products. You’ll be responsible for designing and executing test strategies, both automated and manual, to identify issues early and improve our quality processes. In addition, you’ll manage documentation and tracking to ensure comprehensive records of test results, defects, and resolutions, providing visibility into quality progress. We’re looking for candidates with experience in QA tools and methodologies, a strong understanding of the software development lifecycle, and exceptional analytical skills. Join our QA team and help us deliver reliable software that truly meets the needs of our users.

• Bring your experience in software quality to help craft and formalize our software development procedures and plans.
• Develop and execute software quality assurance plans, including the creation of validation plans, test protocols and risk assessments
• Create and maintain software requirements documents (SRS/SDS) and risk analysis documents, ensuring they accurately reflect design and functional specifications
• Establish traceability between identified risks, mitigations, verifications and validations, and requirements.
• Work closely with the V&V team to help develop and review validation plans and provide guidance on regulatory requirements/guidance on validation activities
• Work closely with Regulatory Affairs to ensure the regulatory strategy aligns with software quality goals and milestones
• Manage Computer Software Assurance (CSA) activities for all non-product software systems and internal tools
• Support external software testing initiatives, performing audits and assessments of third
• Train others on following software quality system processes and mentor them on the quality focused mindset.
• Suggest and implement improvements to the software quality system to make it more effective and less burdensome.
• Support internal and external audits of the software quality system and its records.
• Adhere to and contribute to Vital’s QMS policies, SOPs, etc. to ensure in-vitro diagnostic standards and regulations for the US, CA, and EU are met.