JOB DESCRIPTION

Join us-“”Where your Career is a Force for Good!.

Job Description: WHY CHOOSE US? Joining The American Red Cross is like nothing else -“” it-“”s as much something you feel as something you do. You become a vital part of the world-“”s largest humanitarian network. Joining a team of welcoming individuals who are exceptional, yet unassuming.

Diverse, yet uncompromising in unity. You grow your career within a movement that matters, where success is measured in people helped, communities made whole, and individuals equipped to never stop changing lives and situations for the better. When you choose to be a force for good, you-“”ll have mentors who empower your growth along a purposeful career path.

You align your life-“”s work with an ongoing mission that-“”s bigger than all of us. As you care for others, you-“”re cared for with competitive compensation and benefits. You join a community that respects who you are away from work as much as what you do while at work.

WHAT YOU NEED TO KNOW ABOUT THE JOB: 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 ARC procedures and regulatory requirements. Develops quality plans and recommends updates to existing procedures as required improving and/or strengthening the SDLC and Product Acquisition Life Cycle (PALC). The work location for this position is 100% virtual/work from home.

While the position can be worked from anywhere in the United States, the preferred work hours are on an East Coast schedule. We are seeking a qualified candidate for the position of Delivery Lead, BioPro Project. This is a part-time , term-limited role expected to last through June 2027.

While the position term is anticipated to conclude at that time, there may be an opportunity for extension depending on program/business needs, funding availability, and demonstrated performance. Any extension is not guaranteed and will be communicated in writing if applicable. The American Red Cross may terminate employment at any time, for any legal reason, with or without cause or notice.

WHERE YOUR CAREER IS A FORCE FOR GOOD (Key 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. Scope: Individual contributor that works under limited supervision. Apply subject matter knowledge.

Capacity to understand specific needs or requirements to apply skills/knowledge. Note: Qualified candidates must be authorized to work in the United States. The American Red Cross does not sponsor employment visas.

WHAT YOU NEED TO SUCCEED: Education: Bachelor-“”s degree required or equivalent combination of education and experience. Experience: Minimum 10 years of related experience in a FDA-regulated environment required. Skills & Abilities: Expert level knowledge of work and industry.

Ability to provide innovation solutions and consult on multiple projects and/or initiatives. Excellent organizational skills. Ability to handle multiple priorities effectively, analyze problems, recommend appropriate solu tions, and assimilate information quickly.

Excellent interpersonal, verbal, and written communications skills to deal with all levels of staff and external clients. Proficient with Microsoft office applications. Ability to work on a team.

Travel: May travel 10-20% PAY INFORMATION: The annual salary range for this position is $110K – $125K. We do not offer an annual bonus for this role. Note that American Red Cross salaries are aligned to the specific geographic location in which the work is primarily performed.

Other factors that may be used to determine your actual salary may include your specific skills, how many years of experience you have and comparison to other employees already in this role. **We will review specific salary information at the time of phone screening based upon your location & experience.** This job will be posted for a minimum of five business days and extended if the applicant pool needs to be expanded. BENEFITS FOR YOU: As a mission-based organization, we believe our team needs great support to do great work.

Our comprehensive package includes: Medical, Dental Vision plans Health Spending Accounts & Flexible Spending Accounts PTO: Starting at 19 days a year; based on type of job and tenure Holidays: 11 paid holidays comprised of six core holidays and five floating holidays 401K with up to 6% match Paid Family Leave Employee Assistance Disability and Insurance: Short + Long Term Service Awards and recognition Apply now! Joining our team will provide you with the opportunity to make your career a force for good! The American Red Cross is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers, San Diego Fair Chance Ordinance, the California Fair Chance Act and any other applicable state and local laws.

AmeriCorps, the federal agency that brings people together through service, and its partners -“” the Peace Corps, AmeriCorps Alums, National Peace Corps Association, and the Service Year Alliance -“” launched Employers of National Service to connect national service alumni with opportunities in the workforce. American Red Cross is proud to be an EONS partner and share our employment opportunities with the network of organizations. Interested in Volunteering? Visit redcross.org/volunteertoday to learn more, including our most-needed volunteer positions.

To view the EEOC Summary of Rights, click here: Summary of Rights Joining The American Red Cross is like nothing else -“” it-“”s as much something you feel as something you do. You become a vital part of the world-“”s largest humanitarian network. Joining ranks with welcoming team members who are elite, yet unassuming.

Diverse, yet uncompromising in unity. You grow your career within a movement that matters, where success is measured in people helped, communities made whole, and individuals equipped to never stop changing lives and situations for the better. When you choose to be a force for good, you-“”ll have mentors who empower your growth along a purposeful career path.

You align your life-“”s work with an ongoing mission that-“”s bigger than all of us. As you care for others, you-“”re cared for with generous compensation and benefits. You join a community that respects who you are away from work as much as what you do while at work.