Quality Compliance Leader

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

Benefits offered by this job

Competitive benefits

Career development

Global growth opportunities

Tuition reimbursement

Job summary

Dexcom Inc. is seeking a senior leader in Quality Assurance to drive regulatory compliance, CAPA, and internal auditing across the site. You will oversee document control, monitor QMS performance, and partner with cross-functional teams to maintain patient safety and product quality.

The role requires extensive experience in FDA/regulatory frameworks, ISO 13485, and leading cross-functional quality initiatives. A strong writing skillset and hands-on leadership are essential.

Qualifications

• Bachelor’s degree with 8–12 years in QA/quality roles.
• 2–5 years of management or lead experience.
• Experience with FDA 21 CFR 820 and ISO 13485.
• Strong investigative and root-cause analysis skills.

Responsibilities

• Oversee the site Document Control team and maintain QMS documents.
• Ensure compliance with FDA and ISO standards and drive audits.
• Lead CAPA management and nonconformance investigations.
• Develop and report quality metrics to site leadership.
• Lead internal audit program and site governance.

Skills

Quality Assurance

Regulatory Compliance

Audit Leadership

CAPA Management

Education

Bachelor’s degree

Job description

Dexcom Inc. is seeking a senior leader in Quality Assurance to drive regulatory compliance, CAPA, and internal auditing across the site. You will oversee document control, monitor QMS performance, and partner with cross-functional teams to maintain patient safety and product quality.

The role requires extensive experience in FDA/regulatory frameworks, ISO 13485, and leading cross-functional quality initiatives. A strong writing skillset and hands-on leadership are essential.