RapidAI is transforming clinical decision-making with the worlds 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.
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.