Staff QA Engineer

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 global 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 define, support, and improve the processes that get us there.

Where you come in

• You serve as a technical leader on new high-volume manufacturing automation equipment development teams.
• You interpret and guide the application of regulatory requirements, shape equipment and process design requirements, influence risk-based design decisions, and architect validation strategies across programs.
• You drive Design Control and specifically design transfer strategy for new products, ensuring scalable, high-volume manufacturing readiness across global sites.
• You partner with Operations to optimize the transition from pilot builds through commercial automation deployment.
• You provide manufacturing quality engineering leadership for the development, process validation, and commercialization of new processes.
• You lead complex investigations, guide MRB decision-making, and drive systemic improvements across equipment and process designs.
• You lead alignment across multi-level, cross-functional, and international teams on complex technical and compliance topics, setting direction and resolving ambiguities to ensure consistent implementation across sites.
• You provide expert-level guidance in strengthening and governing the Quality Management System, including FMEA methodology, process validation architecture, CAPA strategy, process controls, and nonconformance management.
• You proactively identify systemic compliance or procedural gaps across programs or sites and lead the teams that develop and implement corrective and preventive actions with cross-functional buy-in.
• You represent the organization during internal audits and external regulatory inspections, providing subject-matter expertise and influencing quality strategy and responses.
• You mentor engineers and cross-functional partners, elevating quality engineering proficiency and ensuring consistent application of best practices across teams.

What makes you successful

• You have deep, hands-on experience with FDA 21 CFR 820, ISO 13485, and related Quality Management System requirements, and you can interpret and apply them at a system and program level.
• You are proficient at reviewing and interpreting complex technical documentation, engineering drawings, and specifications, and you can guide others in doing the same.
• You bring advanced level skills in root cause analysis, Six Sigma methodologies, structured problem solving, test method validation, software validation, process validation, process capability (e.g., Cpk/Ppk), lean manufacturing, sampling plans, and statistical analysis.
• You have strong proficiency in data analysis tools such as Excel and JMP and can guide teams in developing robust data-driven decisions.
• You communicate with clarity and influence across all levels of the organization, ensuring alignment with engineering, operations, leadership, and global partners.
• You formulate and drive implementation of comprehensive, cross-functional quality solutions, gaining alignment across stakeholders and global sites.
• You independently organize, prioritize, and lead strategic initiatives while serving as a key contributor on cross-functional teams.
• You consistently demonstrate initiative, ownership, and integrity in driving high-impact quality and compliance improvements.
• You thrive in a dynamic environment and support the broader quality and operations organizations as needed.

Experience and Education Requirements

Typically requires a Bachelor's degree in a technical discipline, and a minimum of 8-12 years related experience or Master's degree and 5-7 years equivalent industry experience or a PhD and 2-4 years of experience.