Quality Systems Engineer
Core
Design, implement, and optimize software-focused design control systems to ensure regulatory compliance for medical device software development.
Role type
Quality Systems Engineer (Design Controls)
Builds
Scalable, automation-driven compliance infrastructure embedded in engineering workflows
Domain
Medical device software / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
Design controls, software requirements management, basic scripting/automation/querying, traceability frameworks, risk management integration, change control mechanisms, CI/CD pipeline compliance, automated evidence generation
Preferred skills
IEC 62304, FDA Design Controls (21 CFR 820.30), ISO 14971, regulated software development experience
Technologies
Python, SQL
Responsibilities
Design and implement scalable software design controls systems aligned with IEC 62304 and FDA requirements; Develop and maintain end-to-end traceability frameworks linking user needs to verification evidence; Integrate software risk management into design controls; Build change control mechanisms supporting rapid iteration and same-day deployment; Partner with software engineering teams to embed compliance in CI/CD pipelines; Own subsets of the Quality System related to software design controls
Seniority
Mid-level, hands-on IC
