Software Quality Engineer
Core
Ensures software engineering activities and documentation for IVD and digital products meet QMS, regulatory, and standards requirements (IEC 62304, ISO 62366) through review, guidance, and process support.
Role type
Senior IC Software Quality Engineer (Regulated Medical Devices)
Builds
Software-specific QMS processes, SDLC compliance, and audit-ready documentation for IVD products
Domain
Medical Devices / In Vitro Diagnostics / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Software QA in regulated environments, Design controls (ISO 13485), Risk management (ISO 14971), Software lifecycle (IEC 62304), Regulatory submissions, Audit support, CAPA management, Cybersecurity alignment
Preferred skills
Certified Software Quality Engineer (CSQE)
Technologies
None explicitly listed beyond regulatory standards
Responsibilities
Execute software-development Quality activities and support SDLC QMS processes; Provide Quality review for design-control activities (requirements, architecture, code review, V&V); Participate in Design and Development File documentation; Serve as Quality representative for software risk-management; Support validation of non-product software tools; Investigate and resolve software-related nonconformances and CAPAs; Provide Quality input on cybersecurity design-control and risk-management; Support internal and external audits; Monitor evolving regulatory expectations for software in IVDs
Seniority
Senior, hands-on IC
