Director, QA - Product Development Processes

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 Design Quality Engineering (DQE) team at Dexcom is made up of incredibly passionate, collaborative, motivated, and competent people that think big, serve with integrity, and follow through on their commitments without fail.  This team takes ownership in driving Design for Excellence (DfX) methodologies across the product lifecycle of Dexcom's on market products and future innovations, as well as leading strategies and supporting outcomes across our Design Control, Software Development Lifecycle (SDLC), Design Transfer, and Risk Management quality system processes. Where you come in: You will be the accountable global process owner for Dexcom's Design Control and Risk Management quality system processes.  This includes: Ownership of all Design Control and Risk Management procedures, instructions, templates, and tools in all lifecycle phases of Dexcom products that ensure complete end-to-end traceability. Proactively improve processes with state-of-the-art standards, regulations, and organizational feedback. Engaging directly in industry-wide initiatives around Medical Device standards and guidance. Responsibility for process mapping within and to adjacent processes of quality system. Developing and driving training program for the organization that ensures confident execution. Measurement of process effectiveness over time in Quality Management Reviews. Acting as strategy SME for complex situations within processes on project teams/specific issues. You will act as the Quality lead for Design Control and Risk Management Process Activities driven through continuous improvement, CAPA, or Quality Improvement Plans at Dexcom. You will be responsible for leading, organizing, developing, and growing an organization of site Business Process Owners. You and your team will be responsible for representing Design Control and Risk Management during regulatory audits and inquiries alongside work product authors. You will promote cross-functional understanding and adherence to quality standards, quality processes, and regulatory requirements. What makes you successful: Global Design Control process strategic leadership experience Global Risk Management process strategic leadership experience (ISO 14971 and IEC 60812) Risk Management integration into Quality Management Systems experience (FDA QMSR and ISO 13485) Experience implementing enterprise Design Control and Risk Management IT systems Value Stream Mapping and Business Process Mapping expertise Instructor-led training expertise Corrective and Preventive Action (CAPA) expertise Regulatory Inspections and Audits expertise People leadership, team development, and organizational design experience