Sr QA Engineer San Diego, California Posted ago

Meet the team:

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 lead complex quality investigations by driving root cause analysis, CAPAs, NCMRs (including MRB/disposition decision-making), and systemic corrective actions that improve product quality and compliance.
• You provide technical leadership in quality engineering and continuous improvement methodologies, including Six Sigma, Lean Manufacturing, process capability analysis (Cpk/Ppk), Gage R&R, sampling plans, and risk-based problem solving.
• You drive Quality Management System excellence through continuous improvement of procedures, process controls, validation frameworks, FMEAs, and quality processes.
• You own validation and qualification strategies for equipment, processes, test methods, and software V&V, ensuring compliance and product safety throughout the product lifecycle.
• You serve as the quality engineering lead on cross-functional projects, partnering closely with R&D, Regulatory Affairs, Manufacturing, Operations, Engineering, and global teams to achieve successful business outcomes.
• You guide design transfer and commercialization efforts, ensuring new products and processes are successfully scaled from development through high-volume manufacturing.
• You assess and mitigate risk by influencing design decisions, evaluating process changes, and implementing robust controls that ensure reliable product performance and regulatory compliance.
• You identify and close compliance gaps by proactively assessing quality system weaknesses and leading sustainable corrective and preventive actions across sites and functions.
• You communicate complex technical and compliance topics effectively through effective written and verbal communication, influencing stakeholders and driving alignment across cross-functional and international teams.
• You represent Quality during internal audits and external regulatory inspections, providing subject matter expertise and helping shape organizational quality and compliance strategy.

• Your Chemical Engineering or similar degree from accredited College/University with experience supporting regulated manufacturing environments.
• Your advanced 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 developing and executing validation strategies, including IQ/OQ/PQ/PV, test method validation, software V&V, and process validation activities.
• Your proficiency in design transfer and commercialization, 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 proficiency with data analysis tools such as JMP and Excel, leveraging data to generate actionable insights that support business and quality objectives.
• Your ability to communicate complex technical and compliance topics effectively across all organizational levels, influencing stakeholders and presenting confidently to senior leadership.
• Your cross-functional leadership, building alignment across Engineering, Operations, R&D, Regulatory Affairs, and global teams to deliver comprehensive quality solutions.
• Your experience with chemistry in manufacturing and associated risks (polymers and analytical experience preferred).
• Your strong ownership, integrity, and…