Software Design Assurance Quality Engineer
Core
Ensures software design compliance with quality, safety, and regulatory standards throughout the lifecycle by managing documentation, assessing designs, and leading root cause analysis.
Role type
Senior Software Design Assurance Quality Engineer
Builds
High-quality, compliant software products for health technology applications
Domain
Health IT / Medical Devices / Regulatory Compliance
Required skills
Software Development Life Cycle (SDLC), Defect Management, Design for Quality (DFQ), Root Cause Analysis (RCA), CAPA Methodologies, Technical Documentation, Regulatory Requirements, Design Verification Planning, Design Validation Planning, Data Analysis
Preferred skills
Cloud experience, Health IT experience, Privacy and Security Risk Assessment, Continuous Improvement, Product Quality and Reliability
Responsibilities
Facilitate development and management of comprehensive software quality documentation (SRS); Lead assessment of software designs against quality and safety standards; Conduct root cause analysis for software quality issues; Validate key software design inputs (usability, reliability, performance, safety, privacy); Provide oversight of software quality plans and risk management activities; Utilize post-market analytics to monitor software performance and initiate corrective actions; Ensure compliance with global regulations and standards; Mentor teams on quality engineering practices and QMS processes; Monitor and report on key software quality metrics; Identify opportunities for process improvements in software quality engineering.