Sr Quality Assurance Analyst

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.

The Senior Quality Analyst is responsible for maintaining and continuously improving the Quality Management System (QMS) to ensure compliance with applicable regulatory requirements, industry standards, and company procedures. This role serves as a key contributor to audit readiness, CAPA management, complaint investigations, regulatory submission support, management review, quality metrics, and continuous improvement initiatives, while partnering with cross-functional teams to strengthen quality culture and compliance excellence. Essential Duties and Responsibilities Quality Compliance & QMS Support, maintain, and improve QMS processes to ensure compliance with ISO 13485, FDA QSR/QMSR, MDSAP, and company requirements. Review and update quality procedures, records, and documentation. Support Change Control activities and drive quality system improvements. Participate in quality compliance initiatives and regulatory compliance programs. Audit & Inspection Readiness Lead and support internal audits, external audits, walkthroughs, line walks, and mock audits. Coordinate audit activities, responses, and timely closure of audit findings. Support regulatory inspections and maintain site audit readiness. Provide guidance and coaching to process owners on compliance requirements CAPA, Nonconformance & Complaint Management Lead investigations related to CAPA, nonconformances, deviations, and complaints. Perform root cause analysis and ensure effective corrective and preventive actions are implemented. Monitor and trend quality events to identify systemic issues and improvement opportunities. Ensure timely closure and effectiveness verification of CAPAs. Regulatory Submission Support Support regulatory submissions, product registrations, renewals, and change notifications. Prepare, review, and provide quality documentation required for regulatory submissions. Assess the quality and compliance impact of product, process, supplier, and manufacturing changes. Support responses to regulatory agencies, notified bodies, and customer inquiries Quality Metrics & Management Review Analyze quality data and develop metrics, dashboards, and reports. Monitor KPI trends and recommend improvement actions. Support Site Management Review and Quality Review meetings through data analysis and presentation of quality performance. Utilize analytical tools such as Power BI, Excel, and other reporting platforms to support decision-making.

Bachelor's Degree in Quality, Engineering, Science, or a related discipline. Minimum 5–8 years of experience in Quality Assurance, Quality Compliance, or a regulated industry (Medical Device or Pharmaceutical