Senior Software QA Engineer: Postmarket Quality & Risk

Dexcom, Inc.; United States; Remote; USD 96,000 - 160,000; Full time

Benefits offered by this job

Comprehensive benefits

Career growth

Global opportunities

Job summary

Dexcom Corporation is seeking a Senior Software Postmarket Investigator to partner with Regulatory Affairs, Quality Assurance, and R&D teams. You will lead investigations, assess software-related postmarket issues, and drive improvements that enhance patient safety and product reliability.

You will apply data-driven analysis, communicate findings to diverse stakeholders, and support CAPA and risk assessment activities.

Qualifications

• Typically requires a technical degree and extensive experience in medical device quality systems and regulatory requirements.
• Experience supporting software quality engineering activities throughout the product lifecycle.
• Strong understanding of software risk management principles and regulatory expectations.
• Excellent communication and collaboration skills across technical and non-technical stakeholders.

Responsibilities

• Collaborate with Regulatory Affairs, Quality Assurance, R&D, Clinical, and Process Engineering to investigate postmarket issues.
• Drive development and improvement of complaint investigation processes aligned with hazard analysis and product risk assessments.
• Develop and maintain understanding of Dexcom's software ecosystem to evaluate product performance and investigate anomalies.
• Apply structured problem-solving and data-driven methods to lead investigations and identify root causes.
• Synthesize investigation outcomes for technical and non-technical stakeholders with clear recommendations.
• Contribute to postmarket quality processes, including CAPA and Health Hazard Evaluations (HHEs).
• Perform software-focused risk assessments related to cybersecurity, emerging technologies, and postmarket trends.

Skills

Regulatory compliance

Software quality engineering

Problem-solving

Cross-functional collaboration

Data-driven decision making

Risk management

Education

Bachelor’s degree in a technical discipline

Master’s degree or PhD in related field

Tools

Cloud platforms

Distributed systems

Cybersecurity fundamentals

Software architectures

Job description

Dexcom Corporation is seeking a Senior Software Postmarket Investigator to partner with Regulatory Affairs, Quality Assurance, and R&D teams. You will lead investigations, assess software-related postmarket issues, and drive improvements that enhance patient safety and product reliability.

You will apply data-driven analysis, communicate findings to diverse stakeholders, and support CAPA and risk assessment activities.