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Kelly Science, Engineering, Technology & Telecom · 3 days ago

Software Quality Assurance Consultant

United States

Contract

Remote

Senior Level, Lead/Staff

$58/hr - $65/hr

10+ years exp

Kelly Science, Engineering, Technology & Telecom is seeking a Software Quality Assurance Consultant to support the development, testing, validation, and documentation of biomedical software. The role involves providing guidance on established procedures and regulatory requirements while participating in various phases of the Software Development Life Cycle (SDLC).

Staffing & Recruiting

Hiring Manager

Soma Patanaik

Responsibilities

Provides guidance and quality oversight of the development, testing strategy, validation, and documentation of biomedical software, ensuring compliance with established procedures and regulatory requirements

Participates as an integral team member in various phases of the Software Development Life Cycle (SDLC), providing timely and meaningful feedback for project documentation including software requirements, design, test plans, test cases, and summary reports, and ensuring compliant quality product releases. Anticipates issues and develops consensus-based solutions by partnering with project teams

Effectively collaborates as an internal quality consultant to advise or influence business or technical partners, providing guidance on quality and regulatory requirements, advising IT staff and management on quality and regulatory issues, and recommending solutions and best practices

Identifies and executes process improvements to strengthen internal procedures and processes and improve quality and efficiency

Leads or participates on project teams, task forces, and other complex cross-functional teams

Serves as a subject matter expert in Quality Assurance for software and hardware validation

Identifies and investigates software defects and other problems. Serves as an active participant in the development of corrective and preventive action plans, ensuring regulatory requirements are met

Reviews and approve internal procedures, ensuring regulatory requirements are met, and focusing on procedure clarity and efficient processes

Monitors and reports on changing technology, practices, standards, and regulatory and compliance requirements within the biomedical industry

Qualification

FDA-regulated environmentSoftware Development Life CycleRisk managementConfiguration managementCommunication skillsDocumentation skillsTeam collaboration