Sr. Software Quality Assurance Engineer I

Location: Hybrid work, combining in-office work at the corporate headquarters in Del Mar, California with remote work. Applicants must be authorized to work for any employer in the U.S.

Salary: $109,000–$130,000 annually, plus bonus and benefits.

Company

hirify.global develops and manufactures diabetes technology, including the Tandem Mobi system and t:slim X2 insulin pump with Control-IQ+ technology.

What you will do

• Represent quality on cross-functional software product development teams and provide guidance throughout the software lifecycle.
• Review and approve design control deliverables, requirements, risk files, verification and validation records, traceability documentation, and design review outputs.
• Participate in product risk management, software anomaly management, defect investigations, and disposition decisions.
• Verify that software testing and validation activities demonstrate requirements compliance and complete documentation.
• Support software changes, product releases, release readiness, design and development records, and process improvement initiatives.
• Support complaint, field investigation, correction, corrective action, CAPA, audit, and regulatory inspection activities.

Requirements

• Bachelor’s degree in engineering, computer science, software engineering, biomedical engineering, or a related technical discipline.
• At least 5 years of experience in software quality assurance, software quality engineering, or related quality functions in the medical device or another regulated industry.
• Experience supporting software development from concept through commercial release, including mobile, embedded, and web-based technologies.
• Experience with design controls, risk management, software verification and validation, anomaly management, and traceability.
• Knowledge of FDA Quality System Regulation 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, and Good Documentation Practices.
• Strong technical communication, analytical, prioritization, independent working, and cross-functional influence skills.

Nice to have

• Experience with application lifecycle management and defect tracking tools.
• Experience with JavaScript, C, or similar software development technologies.

Culture & Benefits

• Full-time employment with a competitive compensation package.
• Bonus opportunity and a robust benefits package.
• Workplace focused on employee well-being, growth, collaboration, and inclusive participation.
• Employment is subject to a drug test, excluding marijuana, and a background check.