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Sr Director, QMS

Dexcom · San Diego, CA

📍 San Diego, Californiavia workday
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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 :   The Quality Management Systems (QMS) team at Dexcom plays a critical role in ensuring the integrity, compliance, and scalability of our global quality framework. As a strategic function within Global Quality, the team   is responsible for   maintaining   a robust, compliant, and continuously improving QMS that supports product development, manufacturing, and post-market activities across all regions.   We partner cross-functionally with R&D, Regulatory Affairs, Manufacturing, Supply Chain, and Commercial teams to embed quality into every stage of the product lifecycle. Our mission is to enable innovation while   maintaining   the highest standards of safety, compliance, and patient impact. As Dexcom continues to grow globally, the QMS team ensures our processes evolve to meet increasingly complex regulatory requirements while staying efficient and scalable.   Where you come in:    As the Sr. Director of Quality Management Systems, you will provide strategic leadership and oversight for Dexcom’s global QMS, ensuring it meets all applicable regulatory requirements (FDA, ISO 13485, MDR, and other international standards) while supporting business growth and innovation.   You will:   Own and evolve the global QMS strategy, ensuring alignment with corporate   objectives   and regulatory expectations   Lead the design, implementation, and /or   continuous improvement of key QMS processes, including document control, CAPA,   metrics and analytics,   partnership   management,   audit management,   among   others.   Own the   corporate   CAPA program,   ensuring world class execution and   performance.   Drive harmonization and standardization of quality processes across global sites and regions   Establish   a   Quality   I ntelligenc e program that focuses on   risks and developments across the medical device industry.    Own   Project   M anagement   for the Quality   organization, focusing on continuous improvement opportunities.   Ensure inspection readiness at all times   and   assist   with   enterprise-level responses to regulatory inspections and audits   Partner closely with Regulatory Affairs to interpret evolving global regulations and proactively integrate requirements into the QMS   Build, develop, and lead a high-performing,   global   QMS team   Champion a culture of quality, compliance, and continuous improvement across the organization   Leverage digital tools and data analytics to modernize and scale the QMS, improving efficiency and visibility   Provide executive-level reporting on QMS performance, risks, and improvement initiatives   What makes you successful:    You are a strategic, forward-thinking quality leader who can balance compliance with agility in a fast-paced,   innovation -driven environment.   Leadership & Influence   Proven ability to lead and scale global teams, driving alignment across functions and geographies   Strong executive presence with the ability to influence senior leadership and cross-functional stakeholders   Quality & Regulatory Expertise   Deep knowledge of global QMS requirements, including FDA 21 CFR Part 820, ISO 13485, EU MDR, and other international standards   Demonstrated success leading regulatory inspections and audits with positive outcomes   Experience building or transforming QMS frameworks in   a   complex, global organization   Operational Excellence   Track record   of implementing scalable, efficient quality processes that support rapid business growth   Strong systems mindset with experience driving digital transformation within QMS platforms (e.g.,   eQMS   systems)   Data-driven decision-maker who uses metrics to drive continuous improvement   Strategic Mindset   Ability to   anticipate   regulatory trends   and   corporate needs,   and proactively adapt systems and processes   Strong business acumen with an understanding of how   Q uality enables innovation and market success   Collaboration & Communication   Excellent cross-functional collaboration skills, with the ability to translate complex regulatory requirements into practical, business-friendly solutions   Clear and compelling communicator, capable of engaging audiences from frontline teams to executive leadership   What   you’ll   get : A front row seat to   life changing   CGM technology.   Learn about our brave #dexcomwarriors community .   A   full and   c omprehensive benefit s   progra m .   Growth opportunities on a global scale.   Access to   career development through in-house learning programs and/or   qualified   tuition reimbursemen t.   A n   excit

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