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 our dynamic IT department at Dexcom, where innovation meets expertise in cost accounting within our Oracle EBS environment. As a crucial member of our team, you will be at the forefront of optimizing cost accounting processes, ensuring accuracy, efficiency, and compliance. With a supportive and collaborative atmosphere, you will have the opportunity to make a tangible impact on Dexcom's financial operations while working alongside talented professionals who share your passion for excellence. This position will involve supporting multiple APAC IT projects and may entail leading small projects as needed. Dexcom has regional teams in APAC, EMEA and US and this role will be functionally part of this wider team and will operate within its governance framework.
Where you come in:
Serve as the Subject Matter Expert (SME) for validation and compliance of Enterprise and Manufacturing Systems, including MES/Camstar, ERP, QMS, SCADA, PLC, Data Historians, EBR, and other GxP-regulated platforms.
Lead verification and validation activities, including Computer System Validation (CSV), Computer Software Assurance (CSA), Process Validation (IQ/OQ/PQ/PPQ), Test Method Validation, and Validation Master Planning.
Provide QA and QC requirements, guidance, and oversight for IT and Operational Technology (OT) systems while ensuring regulatory compliance and inspection readiness.
Perform GxP risk assessments at the system, functionality, and data-element levels, applying risk management principles, sample size determination, and external standards review.
Serve as a core advisor to IT, OT, Quality, Manufacturing, and cross-functional teams by providing expertise on validation strategies, quality systems, compliance requirements, and risk mitigation.
Ensure compliance with FDA 21 CFR Part 11, FDA 21 CFR 820, ISO 13485, EU MDR, and other applicable domestic and international regulations.
Develop, execute, and maintain validation deliverables throughout the SDLC, including Validation Plans, Protocols, Risk Assessments, Traceability Matrices, Test Scripts, and Summary Reports.
Effectively communicate project progress, validation status, compliance risks, and key challenges to broad Dexcom teams and senior leadership.
Independently lead validation initiatives and project activities across cross-functional teams and projects of varying complexity.
Design and continuously improve policies, procedures, and quality systems supporting validation, auditing, CAPA, calibration, training, document control, customer complaints, nonconforming materials, receiving inspection, and process controls.
Apply Six Sigma, Total Quality Management (TQM), and continuous improvement…