Senior Software QA Engineer - Postmarket & Compliance

Dexcom; San Diego (CA); On-site; USD 96,000 - 160,000; Full time

Benefits offered by this job

Comprehensive benefits

Job summary

Dexcom seeks a postmarket investigations professional to partner with Regulatory Affairs, Quality, and R&D in investigating software- and device-related issues. You will drive root-cause analysis, CAPAs, and risk assessments to ensure patient safety and regulatory compliance.

You will apply structured problem-solving, analyze data trends, and translate findings into actionable improvements across product performance and user experience.

Qualifications

• Knowledge of medical device quality systems and regulatory requirements.
• Ability to apply risk-based decision-making per regulatory expectations.
• Experience with software-focused investigations and CAPAs.
• Strong data interpretation and trend analysis skills.

Responsibilities

• Collaborate with Regulatory Affairs, Quality, R&D, and Clinical teams to investigate postmarket issues.
• Lead and document software- and device-related postmarket investigations.
• Develop and maintain software risk assessments and DFMEA/PFMEA alignment.
• Communicate investigation outcomes to stakeholders with clear recommendations.

Skills

Regulatory knowledge

Software risk mgmt

Statistical analysis

Cross-functional collaboration

Technical communication

Education

Bachelor’s in technical field

Job description

Dexcom seeks a postmarket investigations professional to partner with Regulatory Affairs, Quality, and R&D in investigating software- and device-related issues. You will drive root-cause analysis, CAPAs, and risk assessments to ensure patient safety and regulatory compliance.

You will apply structured problem-solving, analyze data trends, and translate findings into actionable improvements across product performance and user experience.