Quality Engineering Manager

RapidAI; United States; Remote; USD 90,000 - 120,000; Full time

Job summary

A leading company in AI-driven medical solutions seeks a Software Quality Assurance Specialist. The role involves developing and enforcing quality standards, ensuring compliance for software as a medical device, and leading process improvements. Ideal candidates are experienced in Quality Management with strong project management and communication abilities.

Qualifications

• 10+ years of experience in software quality assurance preferred.
• Experience with Quality Management Systems and software as a medical device preferred.

Responsibilities

• Develop and maintain software quality standards and procedures.
• Support regulatory filings and ensure compliance with requirements.
• Lead initiatives for continuous improvement in software quality assurance.

Skills

Organizational skills

Project management

Communication skills

Education

Bachelor of Science Degree

Job description

RapidAI is transforming clinical decision-making with the world’s most advanced AI-driven imaging and care coordination solutions. RapidAI empowers care teams with the deepest clinical insights to accelerate diagnosis, streamline workflows, and improve patient outcomes. Running on the secure and scalable Rapid Edge Cloud, RapidAI solutions drive efficiency, enhance collaboration, and enable faster, more confident treatment decisions. Trusted by hospitals worldwide, RapidAI is setting new standards for coordinated, life-saving care by helping hospitals do and see more with ease.

What you will do:

• Develop, implement, and maintain standards for software quality processes, systems, and procedures to support the software life cycle.
• Ensure that software project and process control documentation are compliant with established procedures.
• Support Research and Development and production for SaMD in Software Quality Assurance.
• Review product requirements for traceability, risk remediation and testability.
• Preparation and analysis of periodic Quality Reports
• Lead specific continuous improvements initiatives which will evolve into a more robust software quality assurance process.
• Support of regulatory filings with technical information for products supported and work toward support to 510(k) process.
• Review verification and validation deliverables for compliance with regulatory requirements.
• Track software problem reports and deviation up to closure.
• Support the development, update, validation, and documentation of software utilized in the testing of SaMD.
• This position does not have direct reports.
• Perform any other related activities assigned by reporting manager.

What you will bring:

• Bachelor of Science Degree with 10+ years of experience preferred.
• Previous experience working with Quality Management System is preferred.
• Previous experience working with software as a medical device is preferred.
• Ability to perform engineering work of a broad nature with little direction from Quality Management. Generally, receives guidance on novel or controversial problems.
• Strong organizational and project management skills with an attention to detail and accuracy
• Strong people and communication skills (oral and written). Understands how to present information dependent upon the level of the audience.

RapidAI is committed to creating an inclusive and diverse workplace. We provide equal employment opportunities to all employees and applicants and prohibit discrimination and harassment of any type in regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.