*Role will be based in Irvine, CA and travel to Lake Havasu, AZ periodically for first 6-8 months for QMS implementation*
- Leads the ongoing implementation of Software Quality Management System (QMS) in conformance with US FDA Quality System Regulations and ISO 13485 Design Controls, through the integration of internal and external/medical device industry best practices.
- Responsible for the administration of the QMS software.
- Collaborates with software development teams in the creation of Design History Files (DHFs) including software development plans, software verification and validation plans, software requirements specifications, software architecture and design documents, design and code reviews, software Risk Management File (RMF), test protocols and reports, traceability matrices.
- Conducts investigations and provides corrective and preventive actions based on analysis and review. Provides and implements effective solutions that will drive continuous and measurable improvements.
- Integrates ISO 14971, risk management and IEC 62366 usability engineering activities with our processes.
- Mentors and provides direction to software development teams in design controls and lead risk management activities.
- Fosters and maintains organizational compliance to the quality system including ongoing training and education on software QMS and framework.
- Provides CAPA, complaints, audit and overall QMS support in regards to software.
- Performs other related duties and projects as business needs require at direction of management.
Education and Experience:
- Bachelor's degree in Computer Science, Software Engineering, Informatics, Biomedical, or related technical field or equivalent practical experience.
- Minimum of eight (8) years of experience in software design assurance in the FDA QSR/ISO 13485 medical device industry.
- Experience with the application of IEC 62304 (Medical Device Software Lifecycle Processes), ISO 14971 (Risk management) and IEC 62366 Usability Engineering.
- Experience with Agile software development methodologies like Scrum and Kanban.
- Experience with other than embedded software development areas, such as web development.
- Previous experience with digital health, Health IT or mobile medical applications required.
- Previous experience with cloud-based software preferred.
- Knowledge of CAD/CAM and AI/ML a plus.