Top 3 Skills:
- Standalone Software as a Medical Device (SaMD)– 3-5 years recent
- Quality management systems (QMS)
- Should be a Quality Engineer/Design Assurance Engineer in recent 3-5 years no managerial experience required.
Red Flag in Resume:
Not Required:
- Experience in Computer System Validation (CSV)
- Experience in Test Engineering (V&V)
- Regulatory Affairs experience (although may be a plus)
Top 3 Daily Responsibilities: (3+ bullets of the main responsibilities on the assignment)
- 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.
