Software QA Engineer II

Summary:

The role of Software Quality Assurance Engineer involves providing expert guidance and support for the launch of software products, sustaining engineering projects, and quality system activities to ensure compliance with established standards.

This position does not entail software development or testing; rather, it focuses on steering software teams in quality assurance, risk management, and compliance activities to ensure the successful launch and ongoing sustainability of software products, while enhancing internal operations for efficiency and quality.

Responsibilities:

• Offer quality support for software project teams across the software lifecycle, from design to launch.
• Ensure seamless integration of quality practices into software development, scientific computation, and data acquisition processes.
• Develop and review various project deliverables throughout the software lifecycle, adhering to procedural requirements.
• Conduct risk analysis and manage risks associated with software projects, documenting them from design to post-launch phases.
• Analyze test results to verify compliance with existing functionality and requirements, suggesting corrective measures if necessary.
• Generate traceability reports to ensure alignment with project requirements.
• Participate in the Software Review Board (SRB) to assess and address software anomalies.
• Review and approve Change Orders (COs) while offering quality insights to facilitate closure (e.g., QMS updates, procedural changes).
• Provide quality input for Complaint, Failure Analysis (FA), Corrective and Preventive Action (CAPA) investigations, and implement corrective actions when necessary.

Desired Skills:

• Proficiency in federal regulations and standards such as Quality System Regulations (QSRs), ISO 14971, and IEC 62304.
• Ability to foster team collaboration and a shared commitment to success.

Qualifications:

• Bachelor's degree in Engineering, Computer Sciences, or a related field, or equivalent combination of education and relevant experience.
• Seeking a candidate with minimum 2-4 years' experience serving as a Quality representative on software projects and guiding cross-functional teams toward compliance in an FDA-regulated environment.
• Authorization to work for any U.S. employer is required; sponsorship for employment visas is not available at this time.