Sr. Software Quality Assurance Engineer I

GROW WITH US:
Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. We’d love for you to team up with us to “innovate every day,” put “people first,” and take the “no-shortcuts” approach that has propelled us to become a leader in the diabetes technology industry.

STAY AWESOME:
Tandem Diabetes Care is proud to manufacture and sell the Tandem Mobi system and t:slim X2 insulin pump with Control-IQ+ technology — an advanced predictive algorithm that automates insulin delivery. But we’re so much more than that. Our company’s human-centered approach to design, development, and support delivers innovative products and services for people who use insulin. Because many of our own team members live with diabetes, or have a loved one impacted by diabetes, the work is personal, and we are committed to the cause. Learn more at tandemdiabetes.com

A DAY IN THE LIFE:

Serves as the Software Quality Assurance Engineer supporting software product development programs, ensuring software products are developed, validated, and maintained in compliance with applicable quality system and regulatory requirements. Applies knowledge of software lifecycle development, quality processes, and risk management to review development activities, identify quality and compliance risks, and provide guidance on quality best practices. Supports continuous improvement of quality processes to meet department, business unit, and company objectives and serves as the quality representative on cross-functional product development teams.

Sr. Software Quality Assurance Engineers at Tandem are also responsible for:

• Serves as a Quality representative on project core teams and provides quality guidance throughout software development activities.
• Reviews and approves design control deliverables, including requirements, risk management files, verification and validation documentation, traceability records, software change assessments, and design review outputs for compliance with company procedures and regulatory requirements.
• Participates in risk management activities, including identification, evaluation, documentation, and maintenance of product risks, and reviews risk management documentation for compliance with company procedures and applicable standards.
• Provides traceability analysis and reporting to ensure requirements, risks, verification, and validation activities are appropriately linked and documented.
• Provides quality oversight of software anomaly management activities, including review of issue assessments, defect investigations, risk evaluations, unresolved anomalies, and disposition decisions in accordance with company procedures and regulatory requirements.
• Reviews software verification and validation activities and associated test results to ensure requirements are met and documentation is complete and compliant.
• Participates in design reviews and evaluates design review evidence for compliance with company procedures and design control requirements.
• Supports maintenance of the Design and Development File and other development records to ensure completeness, traceability, and compliance.
• Provides quality input to software changes, product releases, and release readiness activities.
• Evaluates and recommends quality-related process improvements, tools, and methodologies.
• Supports Complaint, Field Investigation (FI), Correction and Corrective Action (CA), and CAPA investigations and executes assigned corrective actions when applicable.
• Provides quality support during internal, external, customer, and regulatory audits and inspections.
• Ensures work is performed in compliance with company policies, including Privacy/HIPAA requirements, and applicable regulatory, legal, and safety requirements.
• Supports other departments as needed and considers project-wide impacts in decision making.
• Performs other duties as assigned.

WHEN & WHERE YOU’LL WORK:

This role will be a mix of in-office work at our corporate headquarters in Del Mar, CA and remote work.

WHAT YOU’LL NEED:

• Bachelor's degree in Engineering, Computer Science, Software Engineering, Biomedical Engineering, or a related technical discipline
• Minimum 5 years of experience in software quality assurance, software quality engineering, or related quality functions within the medical device or other regulated industry.
• Experience supporting software development from concept through commercial release.
• Experience with Design Controls, risk management, software verification and