Senior Software QA Engineer – Postmarket Quality & Risk

Dexcom; United States; On-site; USD 96,000 - 160,000; Full time

Benefits offered by this job

Comprehensive benefits

Global growth

Tuition reimbursement

Career development

Innovative company

Job summary

Dexcom is seeking a experienced professional to join the Postmarket Investigations team. You will collaborate across Regulatory, Quality, R&D, and Clinical teams to investigate software- and device-related postmarket issues, driving root-cause analyses and data-driven improvements.

The role emphasizes risk-based decision-making, regulatory compliance, and delivering actionable insights to enhance patient safety and product reliability across the Dexcom software ecosystem.

Qualifications

• Bachelor’s degree in a technical discipline; 5–8 years related experience or Master’s with 2–5 years experience or PhD with 0–2 years.
• Experience in software quality engineering across product lifecycle (requirements to postmarket).
• Knowledge of medical device quality systems and regulatory requirements (FDA, ISO etc.).
• Strong analytical and data-driven approach; capable of cross-functional communication.

Responsibilities

• Collaborate with Regulatory Affairs, Quality Assurance, R&D, Clinical, and Process Engineering to investigate postmarket issues.
• Lead development and improvement of complaint investigation processes aligned with risk management activities.
• Understand Dexcom software ecosystem and architecture to evaluate performance and identify improvements.
• Apply structured problem-solving and statistical analysis to root-cause investigations.
• Communicate outcomes to technical and non-technical stakeholders and drive corrective actions.
• Support CAPA, HHEs, and other quality system activities in postmarket workflows.
• Translate postmarket insights into product improvements and patient safety enhancements.

Skills

Regulatory knowledge

Software QA

Risk management

Data analysis

Cross-functional

Cloud basics

Problem solving

Education

Bachelor's degree in technical discipline

Master's degree or PhD (optional)

Tools

DFMEA

PFMEA

Job description

Dexcom is seeking a experienced professional to join the Postmarket Investigations team. You will collaborate across Regulatory, Quality, R&D, and Clinical teams to investigate software- and device-related postmarket issues, driving root-cause analyses and data-driven improvements.

The role emphasizes risk-based decision-making, regulatory compliance, and delivering actionable insights to enhance patient safety and product reliability across the Dexcom software ecosystem.