Senior Software QA Engineer — Remote-Eligible

Tandem Diabetes Care; San Diego (CA); Hybrid; USD 109,000 - 130,000; Full time

Job summary

Tandem Diabetes Care is seeking a Sr. Software Quality Assurance Engineer to ensure software products meet quality and regulatory standards.

You will guide lifecycle activities, review design controls, risk management, and validation across cross-functional teams to support development programs including Tandem Mobi and t:slim X2 platforms. The role emphasizes regulatory knowledge, strong documentation, and collaboration with engineering, regulatory, and manufacturing teams to drive quality

Qualifications

• Bachelor's degree in Engineering, Computer Science, Software Engineering, Biomedical Engineering, or related technical discipline.
• Minimum 5 years of experience in software quality assurance or related quality function within medical device or regulated industry.
• Experience supporting software development from concept through release.
• Knowledge of FDA QSR (21 CFR 820), ISO 13485, ISO 14971, IEC 62304, and related standards.
• Knowledge of Design Controls, risk management, verification/validation, and software anomaly management.

Responsibilities

• Serve as a Quality representative on project teams and provide quality guidance.
• Review and approve design control deliverables, risk management files, V&V, traceability, software change assessments, and design review outputs for compliance.
• Participate in risk management activities and maintain product risk documentation.
• Provide traceability analysis and reporting to link requirements, risks, verification, and validation.
• Provide quality oversight of software anomaly management activities and investigations.
• Review software verification and validation results to ensure they meet requirements and are well-documented.
• Participate in design reviews and evaluate evidence for compliance with procedures.
• Support maintenance of the Design and Development File and other records for completeness and traceability.
• Provide quality input to software changes, product releases, and release readiness.

Skills

QA Engineering

Quality systems

Risk management

Regulatory compliance

Cross-functional communication

Education

Bachelor's degree in Engineering/CS/Software/Biomedical Engineering

Tools

ALM tools

Defect tracking tools

Job description

Tandem Diabetes Care is seeking a Sr. Software Quality Assurance Engineer to ensure software products meet quality and regulatory standards.

You will guide lifecycle activities, review design controls, risk management, and validation across cross-functional teams to support development programs including Tandem Mobi and t:slim X2 platforms. The role emphasizes regulatory knowledge, strong documentation, and collaboration with engineering, regulatory, and manufacturing teams to drive quality