Quality Compliance Manager | FDA/ISO & QMS Lead

Dexcom, Inc.; Mesa (AZ); On-site; USD 111,000 - 185,000; Full time

Benefits offered by this job

Comprehensive benefits

Global growth opportunities

Tuition reimbursement

Job summary

Dexcom, Inc. seeks a Quality Assurance leader to oversee the site’s Document Control within the QMS, ensuring compliance with FDA/ISO standards and driving improvements. You will lead audits, CAPA management, and cross‑functional remediation efforts to maintain audit readiness.

You will manage a QA team, develop metrics, and report quality performance to site leadership, while advancing Dexcom’s mission in CGM technology and patient safety.

Qualifications

• Bachelor’s degree required; 8–12 years of industry experience.
• 2–5 years of previous management or lead experience.
• Knowledge of FDA 21 CFR 820 and ISO 13485 quality systems.

Responsibilities

• Oversee site Document Control within the Quality Management System (QMS).
• Ensure compliance with regulatory standards (FDA/ISO) and drive continuous improvement.
• Lead regulatory submissions related to complaints and change notifications; support audits.

Skills

Regulatory compliance

QMS familiarity

Audits

CAPA management

Leadership

Technical writing

ISO 13485

Education

Bachelor's degree

Job description

Dexcom, Inc. seeks a Quality Assurance leader to oversee the site’s Document Control within the QMS, ensuring compliance with FDA/ISO standards and driving improvements. You will lead audits, CAPA management, and cross‑functional remediation efforts to maintain audit readiness.

You will manage a QA team, develop metrics, and report quality performance to site leadership, while advancing Dexcom’s mission in CGM technology and patient safety.