Senior Software QA Engineer, Postmarket & Risk Analysis

RXinsider LTD.; Mesa (AZ); On-site; USD 96,000 - 159,000; Full time

Job summary

Dexcom seeks a Senior Postmarket Quality Engineer to support software- and device-related postmarket investigations, ensuring patient safety and regulatory compliance. You will drive CAPAs and risk assessments, collaborate across Regulatory Affairs, Quality Assurance, R&D, and Clinical teams, and help translate insights into product improvements.

Role emphasizes data-driven root-cause analysis, cross-functional communication, and continuous improvement of complaint handling and risk management

Qualifications

• Bachelor’s degree in a technical discipline is typically required.
• 5–8 years related experience or Master’s/PhD with 2–5 years equivalent experience.
• Experience with software quality engineering across product lifecycle.

Responsibilities

• Collaborate with Regulatory Affairs, Quality Assurance, R&D, Clinical, and Process Engineering to support investigations and resolution of software- and device-related postmarket issues.
• Drive development and continuous improvement of complaint investigation processes; align with hazard analysis, DFMEA, PFMEA, and product risk assessments.
• Develop and maintain understanding of Dexcom’s software ecosystem and architecture to evaluate product performance and investigate anomalies.
• Apply structured problem-solving and data-driven approaches to root-cause investigations and corrective actions.
• Communicate outcomes to technical and non-technical stakeholders to inform decisions across the organization.
• Contribute to postmarket quality processes, including CAPA, Health Hazard Evaluations (HHEs), and other quality activities.
• Perform software-focused risk assessments related to cybersecurity, emerging technologies, and postmarket trends.
• Partner with product development and quality teams to translate postmarket insights into improvements.

Skills

Software quality engineering

Regulatory requirements

Software risk management

Cross-functional collaboration

Education

Bachelor’s degree in a technical discipline

Master’s degree or PhD (preferred)

Tools

Cloud-based platforms

Job description

Dexcom seeks a Senior Postmarket Quality Engineer to support software- and device-related postmarket investigations, ensuring patient safety and regulatory compliance. You will drive CAPAs and risk assessments, collaborate across Regulatory Affairs, Quality Assurance, R&D, and Clinical teams, and help translate insights into product improvements.

Role emphasizes data-driven root-cause analysis, cross-functional communication, and continuous improvement of complaint handling and risk management