QA Engineer

Join us in empowering people to take control of their health! You will join a collaborative team at the heart of Dexcom’s products. Our quality engineering team plays a crucial role in cross-site and cross-functional alignment for the future of Dexcom and for the future of our customers’ health. You will support Dexcom in bringing state-of-the-art innovative technology to patients and will help to define, support, and improve the processes that get us there.

A positive and team-oriented attitude is important while working in a fast-paced environment and dealing with shifting priorities.

• You support and independently execute quality investigations, including root cause analysis, CAPAs, NCMRs, and MRB/disposition activities, and implement corrective actions that improve product quality and compliance.
• You apply quality engineering and continuous improvement methodologies, such as Six Sigma, Lean Manufacturing, process capability analysis (Cpk/Ppk), Gage R&R, sampling plans, and risk-based problem solving.
• You support the effectiveness and continuous improvement of the Quality Management System through updates to procedures, process controls, validation practices, FMEAs, and other quality processes.
• You develop, review, and execute validation and qualification documentation for equipment, processes, test methods, and software, following applicable procedures and regulatory requirements.
• You provide quality engineering support for cross-functional projects, partnering with R&D, Regulatory Affairs, Manufacturing, Operations, Engineering, and global teams to meet project and quality objectives.
• You support design transfer and commercialization activities by reviewing requirements, evaluating manufacturing readiness, identifying quality risks, and helping transition new products and processes into manufacturing.
• You perform and document risk assessments, evaluate process and design changes, and recommend appropriate controls to support product performance and regulatory compliance.
• You represent Quality during audits and inspections within your assigned areas of responsibility.

• Your Engineering, Chemistry or similar degree from accredited College/University with experience supporting regulated manufacturing environments.
• Your quality engineering knowledge, including risk management, root cause analysis, Six Sigma, process capability analysis (Cpk/Ppk), statistical analysis, sampling plans, AQL, and data-driven decision-making.
• Your demonstrated experience supporting and executing validation activities, including IQ/OQ/PQ/PV, test method validation, software V&V, and process validation activities.
• Your experience supporting design transfer or commercialization activities, applying risk-based decision making to successfully transition new products and processes from development into high-volume manufacturing.
• Your strong technical aptitude with a hands-on approach, partnering directly with manufacturing teams to assess risk, troubleshoot issues, and drive sustainable process improvements.
• Your experience using JMP/Minitab/Excel or comparable statistical software.
• Your ability to communicate complex technical and compliance topics effectively.
• Your experience collaborating with Engineering, Operations, R&D, Regulatory Affairs, and global teams to deliver comprehensive quality solutions.
• Your experience with chemistry in manufacturing and associated risks.
• Your accountability, integrity, and ability to organize and prioritize work while supporting multiple quality initiatives in a fast-paced environment.

• A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.
• A full and comprehensive benefits…