Software QA Engineer 2

📋 Description

• • Support software quality activities related to post-market product performance, customer complaints, software anomalies, and product investigations for continuous glucose monitoring (CGM) devices.
• • Conduct technical investigations of software-related issues using complaint data, field intelligence, system logs, and engineering analysis to identify root causes and quality trends.
• • Partner with cross-functional teams including R&D, Systems Engineering, Quality, Regulatory Affairs, Clinical Affairs, and Risk Management to evaluate software defects and their impact on product safety and performance.
• • Support CAPA (Corrective and Preventive Action) investigations, product performance assessments, and verification activities tied to software quality improvements.
• • Analyze post-market data and product performance trends to identify opportunities for enhancements in product design, processes, and quality systems.
• • Collaborate with development and test engineering teams to ensure software defects are accurately documented, prioritized, tracked, and resolved in alignment with quality standards.
• • Assist in maintaining compliance with product development processes, quality system requirements, and applicable regulatory standards throughout the product lifecycle.
• • Participate in design reviews, defect triage discussions, and quality planning activities for both new product development and sustaining engineering efforts.
• • Interpret software requirements, test results, investigation findings, and customer feedback to support data-driven quality decisions.
• • Utilize data analysis tools, defect tracking systems, and quality management systems to manage and report on software quality metrics.
• • Ensure adherence to FDA Quality System Regulation (21 CFR Part 820), IEC 62304, ISO 13485, and ISO 14971 standards in all software quality activities.
• • Engage in hazard analysis and risk assessment methodologies to evaluate potential software-related safety risks.
• • Travel up to 15% to support cross-functional initiatives, site visits, or quality review meetings as required.
• • Contribute to a culture of continuous improvement by translating real-world product performance data into actionable engineering and quality enhancements.
• • Work within a regulated medical device environment where software quality directly impacts patient safety and health outcomes.
• • Maintain awareness of evolving regulatory expectations and industry best practices in software quality engineering for healthcare technology.
• • Actively participate in the Customer Advocacy Engineering team’s mission to transform post-market insights into actions that improve product safety, performance, and patient experience.
• • Support the broader organizational goal of expanding Dexcom’s vision beyond diabetes to empower individuals with personalized, actionable health insights.