Senior Quality & Compliance Manager (QMS Lead)

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

Benefits offered by this job

Comprehensive benefits

Career development opportunities

Tuition assistance

Job summary

Dexcom is seeking a senior Quality Assurance leader to oversee the site Document Control team within the Quality Management System. You will ensure ISO 13485 and FDA compliance, monitor QMS metrics, and drive continuous improvement across audits, CAPAs, and regulatory submissions.

With 8–12 years of industry experience and 2–5 years in management, you will partner across Engineering, Supply Chain, and Operations to uphold patient safety and product quality.

Qualifications

• Knowledge of FDA 21 CFR 820 and ISO 13485 quality management systems.
• Experience using risk-based methods (FMEA, DOE) for decision making.
• Proven ability to lead audits and regulatory submissions.

Responsibilities

• Oversee site Document Control team and maintain QMS documents.
• Ensure compliance with regulatory standards and monitor QMS performance metrics.
• Facilitate internal and external audits and coordinate CAPA programs.
• Lead remediation of quality system gaps and drive audit readiness.
• Develop and report compliance metrics to site leadership.

Skills

FDA QA compliance

ISO 13485

Quality Systems

Root cause analysis

Cross-functional leadership

Analytical tools

Education

Bachelor’s degree

Job description

Dexcom is seeking a senior Quality Assurance leader to oversee the site Document Control team within the Quality Management System. You will ensure ISO 13485 and FDA compliance, monitor QMS metrics, and drive continuous improvement across audits, CAPAs, and regulatory submissions.

With 8–12 years of industry experience and 2–5 years in management, you will partner across Engineering, Supply Chain, and Operations to uphold patient safety and product quality.