Please use Google Chrome or Mozilla Firefox when accessing Candidate Home.By joining the American Red Cross you will touch millions of lives every year and experience the greatness of the human spirit at its best. Are you ready to be part of the world's largest humanitarian network?Join us—Where your Career is a Force for Good!Job Description:Why Choose Us?As one of the nation’s premier humanitarian organizations, the American Red Cross is dedicated to helping people in need throughout the United States and, in association with other Red Cross networks, throughout the world. When you join our team, you have a direct impact on a meaningful mission, and you can help save lives every day. If you share our passion for helping people, join us in this excellent career opportunity. Work where your career is a force for good.We are committed to the diversity of our workforce and to delivering our programs and services in a culturally competent manner reflecting the communities we serve. Our work environment is collaborative, respectful, and inclusive with a focus on building allyship and a culture of belonging that empowers all team members. Come to learn, grow, and succeed while sharing your passion for making a difference.The Red Cross supports a variety of cultural and community resource groups for employees and volunteers. From the Ability Network, our Asian American & Pacific Islander Resource Group, the Latino Resource Group, and Red Cross PRIDE, to the Umoja African American Resource Group, our Veterans+ Resource Group, and the Women’s Resource Group, these networks provide connections, mentoring and help give voice to important concerns and opinions.At the American Red Cross, your uniqueness can shine!What You Will Do:ResponsibilitiesProvides 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.WHAT YOU NEED TO SUCCEED :QualificationsEducation: Bachelor’s degree required or equivalent combination or work experience and education.Experience: Minimum 7 years of related experience required. Experience working in an FDA-regulated environment required.Skills & Abilities:
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
Other unit-specific experience or qualifications may be required.
The salary range for this position is $100,000-$103,00 annually.Note: that the American Red Cross sets salary ranges aligned to a specific geographic location in which the work is performed. The stated salary range in this posting is an average. The specific salary information will be shared at the time of phone screening based upon your location and qualifications.BENEFITS FOR YOU:We take care of you, while you take care of others. As a mission-based organization, we believe our team needs great support to do great work. Our comprehensive benefits help you in balancing home and work. With our resources and perks, you have amazing possibilities at the American Red Cross to advance the learn.
Medical, Dental Vision plans
Health Spending Accounts & Flexible Spending Accounts
PTO + Holidays
401K with 5% 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 a difference every day.The American Red Cross is an Equal Opportunity/Affirmative Action 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.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 (https://www.americorps.gov/partner/partnerships/employers-national-service) partner and share our employment opportunities with the network of organizations.Interested in Volunteering? Visit redcross.org/volunteertoday (https://www.redcross.org/volunteer/become-a-volunteer/urgent-need-for-volunteers.html) to learn more, including our most-needed volunteer positions.To view the EEOC Summary of Rights, click here: Summary of Rights (https://www.eeoc.gov/sites/default/files/2022-10/EEOCKnowYourRightsscreenreader1020.pdf)