The Company
Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.
We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.
Meet the team:
Join us in empowering people to take control of their health! You will join a collaborative team at the heart of Dexcomâs products. Our quality engineering team plays a crucial role inglobalcross-site and cross-functional alignment for the future of Dexcom and for the future of our customersâ health. You will support Dexcom in bringingstate-of-the-artinnovative 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 leaderonnew highâvolume manufacturing automation equipment development teams. You interpret and guide the application of regulatory requirements, shape equipment and process design requirements, influence riskâbased design decisions, and architect validation strategies across programs.
You drive Design Control andspecificallydesign transferstrategyfor new products, ensuring scalable, highâvolume manufacturing readiness across global sites. You partner with Operations tooptimizethe 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 decisionâmaking, and drive systemic improvements across equipment and process designs.
You lead alignment across multiâlevel, crossâfunctional, and international teams on complex technical and compliance topics, setting direction and resolving ambiguities to ensure consistent implementation across sites.
Youprovideexpertâlevel guidance in strengthening and governing the Quality Management System, including FMEAmethodology,processvalidation architecture, CAPA strategy, process controls, and nonconformance management.
You proactivelyidentifysystemic compliance or procedural gaps across programs or sites and lead the teams that develop and implement corrective and preventive actions with crossâfunctional buyâin.
Yourepresentthe organization during internal audits and external regulatory inspections, providing subjectâmatterexpertiseand influencing quality strategy and responses.
You mentor engineers and crossâfunctional partners, elevating quality engineeringproficiencyand ensuring consistent application of best practices across teams.
What makes you successful:
You have deep, handsâon 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.
Youare proficientat reviewing and interpreting complex technical documentation, engineering drawings, and specifications, and you can guide others in doing the same.
You bringadvancedlevel 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 strongproficiencyin data analysis tools such as Excel and JMP and can guide teams in developing robust dataâdriven 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, crossâfunctional quality solutions, gaining alignment across stakeholders and global sites.
You independently organize, prioritize, and lead strategic initiatives while serving as a key contributor on crossâfunctional teams.
You consistentlydemonstrateinitiative, ownership, and integrity in driving highâimpact quality and compliance improvements.
You thrive in a dynamic environment and support the broader quality andoperationsorganizations as needed.
Whatyouâllget:
A front row seat tolife changingCGM technology.Learn about our brave #dexcomwarriors community.
Afull andcomprehensive benefitsprogram.
Growth opportunities on a global scale.
Access tocareer development through in-house learning programs and/orqualifiedtuition reimbursement.
Anexcitingandinnovative,industry-leading organizationcommitted to our employees,customers, and the communities we serve.Â
Travel Required:
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