Sr Software QA Engineer
Core
Lead postmarket investigations for software and device issues to ensure patient safety, product reliability, and regulatory compliance.
Role type
Senior Software QA Engineer (Postmarket Investigations)
Builds
Continuous glucose monitoring (CGM) devices and software ecosystem
Domain
Medical device / Consumer health technology
Deliverable
client delivery
Required skills
Medical device quality systems knowledge, software risk management, structured problem-solving, statistical analysis, regulatory compliance expertise, cross-functional collaboration
Preferred skills
Cloud platform knowledge, cybersecurity fundamentals, data-driven application experience
Technologies
FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, IEC 82304, EU MDR
Responsibilities
Investigate and resolve software- and device-related postmarket issues; develop and improve complaint investigation processes; conduct software-focused risk assessments; analyze data to identify root causes; communicate findings to stakeholders; contribute to CAPA and Health Hazard Evaluations.
Seniority
Senior, hands-on IC
