Senior Manager of Quality Compliance CAPA

DexCom • San Diego, CA

10d • Remote

About The Position

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 Senior Manager Quality Compliance, CAPA Program is a strategic quality leadership role responsible for the design, execution, and continuous improvement of Dexcom’s global Corrective and Preventive Action (CAPA) program. This role owns the CAPA quality system end-to-end and leads a team of CAPA Coaches who support cross-functional partners in driving timely, effective, and compliant issue resolution. The ideal candidate is a seasoned quality systems leader with deep expertise in CAPA regulations, strong leadership skills, and a proven ability to influence at all levels of the organization. This role is critical to maintaining regulatory compliance, inspection readiness, and a culture of sustainable continuous improvement.

Requirements

• Experience scaling or transforming a CAPA program in a fast-growing organization.
• Strong background in risk management (ISO 14971) and linkage between CAPA and risk.
• Experience with electronic QMS (eQMS) platforms.
• Strategic thinker with strong execution discipline
• Influential leader with the ability to drive alignment without authority
• Excellent written and verbal communication skills
• High judgment and comfort making decisions in complex, ambiguous situations
• Typically requires a Bachelor’s degree with 13+ years of industry experience
• 5-8 years of previous people management experience

Nice To Haves

• ASQ certification (CQA, CQE) or equivalent.

Responsibilities

• CAPA Program Leadership Own and continuously improve Dexcom’s global CAPA process to ensure compliance with QMSR/ISO 13485/MDSAP and global regulatory expectations.
• Serve as the final quality authority for CAPA-related decisions, including adequacy of root cause, correction vs. corrective action, and effectiveness verification.
• Team Leadership & Development Lead, coach, and develop a team of Sr. CAPA Engineers, ensuring consistent application of CAPA principles and high-quality outcomes.
• Build team capability in root cause analysis, risk management, investigation techniques, and effectiveness checks.
• Cross-Functional Influence Partner with Manufacturing, R&D, Operations, Post-Market Surveillance, Regulatory Affairs, and Supply Chain to ensure CAPAs are effectively driven to closure.
• Act as a trusted advisor to functional leaders on CAPA strategy, systemic issue resolution, and compliance risk.
• Inspection & Audit Readiness Represent the CAPA program during FDA inspections, notified body audits, and internal audits .
• Ensure CAPA-related responses to regulatory observations (e.g., 483s, audit findings) are robust, timely, and sustainable.
• Metrics, Reporting & Continuous Improvement Define and monitor CAPA KPIs (e.g., cycle time, aging, effectiveness, recurrence).
• Use data analytics and trend analysis to identify systemic quality issues and improvement opportunities.

Benefits

• A front row seat to life changing CGM technology.
• Learn about our brave #dexcomwarriors community .
• A full and comprehensive benefits program.
• Growth opportunities on a global scale.
• Access to career development through in-house learning programs and/or qualified tuition reimbursement.
• An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level