Offer summary

Qualifications:

4-year college degree required., 10-15 years of experience in software quality assurance., Knowledge in FDA-regulated environments, preferably with medical devices or GMP., Exceptional communication and documentation skills. .

Key responsibilities:

Support development, testing, validation, and documentation of biomedical software.

Provide guidance and quality oversight throughout the Software Development Life Cycle (SDLC).

Collaborate with project teams to ensure compliance with quality and regulatory requirements.

Identify process improvements and lead cross-functional teams to enhance quality and efficiency.

Job description

Job Description:
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.
Responsibilities:

This Software Quality Assurance will be supporting the internal team on this highly complex and mission critical project. This is a fully remote position. East Coast hours.
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.

Requirements:

4-year college degree. Experience: 10 - 15 years.
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.