Software Quality Assurance Consultant

Job 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.
  
  

Qualifications:

Education: 4 year college degree. Experience: 10 - 15 years. Other Skills:

• Knowledge and/or experience in an FDA-regulated environment required, background in medical devices or GMP is strongly preferred
• Excellent understanding of software development life cycle, risk management, and configuration management
• Exceptional communication and documentation skills
• Ability to work as part of a multi-disciplinary teams in a fast-paced environment
  
  

Job Summary:

Supports development, testing, validation and documentation of biomedical software by participating as an integral team member in various phases of the System Development Life Cycle (SDLC), providing guidance on established Red Cross procedures and regulatory requirements. Develops quality plans and recommends updates to existing procedures as required improving and/or strengthening the SDLC.