Quality Compliance Leader (QMS & Audits)

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

Benefits offered by this job

Full benefits program

Career development programs

Tuition reimbursement

Job summary

Dexcom, Inc. is seeking a senior Quality Assurance leader responsible for site QMS compliance, audits, and CAPA governance.

You will oversee document control and remediation activities, drive quality improvements across manufacturing and supply chain, and partner with cross-functional teams to ensure patient safety and regulatory readiness. You will lead the site Internal Audit program, report quality metrics to leadership, and develop robust processes to sustain compliance with ISO 13485 and

Qualifications

• Typically requires a Bachelor's degree and 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 management systems.

Responsibilities

• Oversee site Document Control and ensure QMS compliance.
• Lead internal/external audits and regulatory submissions support.
• Drive continuous improvement, remediation activities, and quality metrics reporting.
• Develop and manage CAPA governance and MRB processes.
• Coach cross-functional teams to ensure patient safety and product quality.

Skills

Quality Assurance

FDA 21 CFR 820

ISO 13485

Leadership

Technical writing

Root cause analysis

CAPA management

Risk-based decision making

Education

Bachelor's degree

Tools

5 Whys

Fishbone diagram

FMEA

DOE

Job description

Dexcom, Inc. is seeking a senior Quality Assurance leader responsible for site QMS compliance, audits, and CAPA governance.

You will oversee document control and remediation activities, drive quality improvements across manufacturing and supply chain, and partner with cross-functional teams to ensure patient safety and regulatory readiness. You will lead the site Internal Audit program, report quality metrics to leadership, and develop robust processes to sustain compliance with ISO 13485 and