The Quality Engineering Manager will develop and maintain software quality processes and standards, support regulatory filings, review product requirements for compliance, and lead continuous improvement initiatives. They will also analyze quality reports and support the engineering team in SaMD testing and documentation.
Company Overview:
At iSchemaView/RapidAI, we believe in leveraging cutting-edge technology and research to impact millions of lives. Our software products enhance doctors’ capabilities across hospitals worldwide to respond to and make the best decisions for patients quickly. We are looking for a high-energy employee who is excited to be at the forefront medical device software development. The successful candidate will meet the criteria defined below, and in doing so, will help deliver the best patient care to patients all around the world.
Position Duties And Responsibilities:
- 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.
Education, Experience, And Qualification
- Bachelor of Science Degree with 5+ 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.
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