Senior Software QA Engineer - MedTech Postmarket Compliance

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

Benefits offered by this job

Comprehensive benefits package

Global career growth opportunities

Tuition reimbursement

Job summary

Dexcom is seeking a candidate for postmarket investigations within the Customer Advocacy/Quality space. You will collaborate with Regulatory Affairs, Quality Assurance, R&D, Clinical, and Process Engineering to investigate software- and device-related postmarket issues and drive quality improvements.

The role emphasizes data-driven investigations, risk management, and cross-functional communication to support patient safety and product reliability in a fast-paced CGM environment.

Qualifications

• Bachelor’s degree in a technical discipline; 5–8 years of related experience, or Master’s with 2–5 years, or PhD with 0–2 years.
• Experience with software quality engineering across product lifecycle.
• Strong understanding of software risk management and regulatory expectations.

Responsibilities

• Support investigation, documentation, and resolution of software- and device-related postmarket issues.
• Develop and maintain complaint investigation processes and risk management activities.
• Evaluate product performance and identify opportunities for improvement.
• Lead data-driven investigations and communicate outcomes to stakeholders.
• Support CAPA, HHEs, and other quality system activities.

Skills

Regulatory knowledge

Software quality

Data analysis

Cross-functional collaboration

Communication

Education

Bachelor's degree in a technical discipline

Master's degree in a technical discipline

PhD (optional)

Tools

FDA 21 CFR Part 820

IEC 62304

ISO 13485

ISO 14971

IEC 82304

EU MDR

Job description

Dexcom is seeking a candidate for postmarket investigations within the Customer Advocacy/Quality space. You will collaborate with Regulatory Affairs, Quality Assurance, R&D, Clinical, and Process Engineering to investigate software- and device-related postmarket issues and drive quality improvements.

The role emphasizes data-driven investigations, risk management, and cross-functional communication to support patient safety and product reliability in a fast-paced CGM environment.