Manager Quality Assurance

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.

Summary:

Quality Assurance Manager – Document Control & Training is responsible for leading the Document Control and Training team while managing the organization’s Quality Management System (QMS). This role ensures compliance with ISO 13485, FDA regulations, and other applicable standards by maintaining robust document control processes, overseeing employee training programs, and driving continuous improvement initiatives. The position responsible for supporting audits, regulatory inspections, and cross-functional collaboration to uphold quality and regulatory requirements.

Essential Duties and Responsibilities:

• Lead Document Control and Training Team

• Oversee the creation, review, approval, and maintenance of controlled documents within the Quality Management System (QMS).
• Ensure timely document revisions and compliance with regulatory and internal requirements.
• Manage training programs to ensure employees are trained on applicable procedures and standards.
• Champion mandatory quality training and a preventive quality culture; lead CI initiatives that simplify processes, strengthen compliance, and improve performance.

• Quality Management System (QMS) Oversight

• Ensuring compliance with ISO 13485, FDA, and other applicable regulatory standards.
• Maintain and improve QMS processes, including document control, training, CAPA, internal audits, and management reviews.
• Monitor QMS performance metrics and drive continuous improvement initiatives.
• Facilitate internal/external audit within the organization

• Regulatory and Audit Support

• Prepare for and support internal, external, and regulatory audits.
• Ensure readiness and compliance for inspections and certifications.

• Cross-Functional Collaboration

• Partner with Quality, Operations, and other departments to ensure alignment with QMS requirements.
• Provide guidance and training on QMS processes and compliance expectations.

Required Qualifications:

• Minimum 10 years of experience in Quality Assurance within a regulated industry (medical device or pharmaceutical preferred).
• Strong knowledge of ISO 13485, 21 CFR 820, ISO 14971, and EU MDR; hands‑on audit hosting and inspection readiness
• Proven experience in document control systems and training program management.
• Demonstrated ability to lead teams and manage QMS processes effectively.
• Excellent communication, organizational, and problem-solving skills.

Preferred Qualifications:

• Experience with electronic document management systems (EDMS) and Learning Management Systems (LMS).
• Familiarity with risk management, CAPA, and audit processes.
• Prior experience in a Quality Management System leadership role.

•  Lean/Six Sigma or similar continuous improvement certification.

Education Requirements:

• Bachelor’s degree in Quality, Engineering, Sciences, or related field.
• Advanced degree or professional certifications (e.g., ASQ CQE, CQA) is a plus.

To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.