Design Quality Engineer (SaMD)
**No C2C or IC Candidates. Must be open to W2 Hourly.
Responsibilities
- Participate in ongoing implementation of Software Quality Management System (QMS) in conformance with US FDA Quality System Regulations and ISO 13485 Design Controls, as well as SDLC processes and tool initiatives, through the integration of internal and external/medical device industry best practices.
- Support 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 and traceability matrices.
- Support integration of ISO 14971 risk management and IEC 62366 usability engineering activities with SDLC processes.
- Guide software development teams in design controls and risk management activities.
- Foster organizational compliance to the quality system, including ongoing training and education on software QMS and SDLC framework. Provide CAPA, complaints, audit and overall QMS support in regards to software.
Qualifications
Minimum qualifications:
- BA/BS degree in Computer Science, Software Engineering, Informatics, Biomedical, related technical field or equivalent practical experience.
- 5-10 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), AAMI TIR45, ISO 14971 (Risk management) and IEC 62366 Usability Engineering.
- Experience in project management, training and working collaboratively with software development teams.
