Manager Quality Compliance

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: Our Quality organization is at the heart of everything we do. We are a collaborative, mission‑driven team committed to ensuring that every device we bring to market is safe, effective, and meets the highest standards of regulatory compliance. As part of the Quality Assurance (QA) Team, you’ll join a diverse group of professionals who work cross‑functionally with Engineering, Supply Chain, and Operations to uphold our commitment to patient safety and product excellence. We work closely with teams across the company to support design controls, validation activities, CAPA management, supplier quality, and product lifecycle initiatives while keeping focus on producing high quality product for our patients. We believe quality is everyone’s responsibility—and we lead by example. Where you come in: You will oversee the site Document Control team who are responsible for overseeing the creation, review, approval, and maintenance of controlled documents within the Quality Management System (QMS). You will be responsible for ensuring compliance with ISO 13485, FDA, and other applicable regulatory standards. You will monitor QMS performance metrics and drive continuous improvement initiatives. You will facilitate internal/external audits within the organization. You will support regulatory submissions related to complaints, submissions and change notifications to notified body. Lead cross-functional discussions to identify and address site needs, ensuring operations remain aligned with the facility's approved scope of work and compliance obligations. You will lead remediation activities related to quality system gaps, observations, and compliance risks and ensure a state of audit readiness across all quality system processes. You will be responsible for developing and reporting compliance metrics to site leadership, analyze quality trends and identify emerging compliance risks. You will present quality system performance during management reviews and business reviews. You will be responsible for the site Internal Audit program by developing annual and multi-year audit schedules based on regulatory requirements, risk assessments, prior audit findings, and quality system performance. You will ensure compliance to in-house and external specifications and standards. Provide guidance on NCMR dispositions and investigations and guidance on the CAPAs. You will develop, manage, and facilitate site-wide Quality, CAPA, and MRB governance forums to ensure the efficient escalation, investigation, documentation, and resolution of quality issues while driving compliance, accountability, and continuous improvement. You will manage a team of Quality