Software QA Engineer 2

Dexcom • Remote California, CA

4d • $78,900 - $131,500

About The Position

The Customer Advocacy Engineering team transforms post-market insights into actions that enhance product safety, performance, and patient experience. In close partnership with R&D, Quality, Clinical, and Regulatory, the team identifies product trends, leads complex investigations, and ensures learnings are translated into improvements across both sustaining products and new product development. This role will support software quality activities related to post-market product performance, customer complaints, software anomalies, and product investigations. The engineer will conduct technical investigations of software-related issues using complaint data, field intelligence, logs, and engineering analysis to identify potential root causes and quality trends. They will partner with cross-functional teams including R&D, Systems Engineering, Quality, Regulatory Affairs, Clinical Affairs, and Risk Management to evaluate software defects and their potential impact to product safety and performance. The role also involves supporting CAPA investigations, product performance assessments, and verification activities associated with software quality improvements. Analyzing post-market data and product performance trends to identify opportunities for product, process, and quality system improvements is key. Collaboration with development and test engineering teams to ensure software defects are appropriately documented, investigated, prioritized, and resolved is expected. The engineer will also assist in maintaining compliance with product development processes, quality system requirements, and applicable regulatory standards throughout the product lifecycle, and participate in design reviews, defect triage discussions, and quality planning activities for new product development and sustaining engineering efforts.

Requirements

• Experience working with software products in a regulated environment, preferably medical devices, healthcare technology, or related industries.
• Working knowledge of software development lifecycle (SDLC), software quality engineering principles, and defect management processes.
• Familiarity with risk management processes and standards, including hazard analysis and risk assessment methodologies.
• Understanding of FDA Quality System Regulation (21 CFR Part 820), IEC 62304, ISO 13485, ISO 14971, or similar quality and regulatory frameworks.
• Strong analytical and problem-solving skills with the ability to evaluate complex technical issues and identify actionable solutions.
• Ability to interpret software requirements, test results, investigation findings, and customer feedback to support quality decisions.
• Effective communication and collaboration skills with the ability to work across multiple technical and business functions.
• Experience working with data analysis tools, defect tracking systems, and quality management systems.

Nice To Haves

• Experience with cybersecurity, software verification and validation, failure analysis, or complaint handling processes.
• ASQ Certified Software Quality Engineer (CSQE) certification.

Responsibilities

• Support software quality activities related to post-market product performance, customer complaints, software anomalies, and product investigations.
• Conduct technical investigations of software-related issues using complaint data, field intelligence, logs, and engineering analysis to identify potential 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 potential impact to product safety and performance.
• Support CAPA investigations, product performance assessments, and verification activities associated with software quality improvements.
• Analyze post-market data and product performance trends to identify opportunities for product, process, and quality system improvements.
• Collaborate with development and test engineering teams to ensure software defects are appropriately documented, investigated, prioritized, and resolved.
• 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 new product development and sustaining engineering efforts.

Benefits

• A full and comprehensive benefits program.
• Growth opportunities on a global scale.
• Access to career development through in-house learning programs and/or qualified tuition reimbursement.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level