Sr 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. Responsibilities You serve as the Quality Engineer on project 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 production. 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. Qualifications You have 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. Benefits A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community. 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. An exciting and innovative, industry‑leading organization committed to our employees, customers, and the communities we serve. Travel Required 5-15% Experience and Education Requirements Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 5-8 years related experience or a Master’s degree and 2-5 years equivalent industry experience or a PhD and 0-2 years experience. Job Disclaimer Please note: The information contained herein is not intended to be an all‑inclusive list of the duties and responsibilities of the job, nor are they intended to be an all‑inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Equal Opportunity Employer An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against based on disability. Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at View email address on click.appcast.io. Salary $87,000.00 - $145,000.00 #J-18808-Ljbffr