Quality Compliance Lead, FDA/ISO & Audits

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

Benefits offered by this job

Comprehensive benefits program

Career development opportunities

Tuition reimbursement

Job summary

Dexcom Inc. is seeking a senior Quality Assurance leader to oversee the site Document Control team within the Quality Management System. You will drive regulatory compliance, audits, and continuous improvement to ensure patient safety and product excellence.

You will lead cross‑functional efforts with Engineering, Supply Chain, and Operations, reporting quality performance to site leadership and managing a team of QA professionals across levels.

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 preferred.

Responsibilities

• Oversee the site Document Control team within the QMS.
• Ensure compliance with FDA and ISO 13485; monitor QMS metrics.
• Lead audits and remediation of quality system gaps; drive CAPAs.

Skills

Quality processes

Regulatory compliance

Leadership

Technical writing

Risk assessment

Education

Bachelor’s degree

Tools

QMS

Documentation control tools

Job description

Dexcom Inc. is seeking a senior Quality Assurance leader to oversee the site Document Control team within the Quality Management System. You will drive regulatory compliance, audits, and continuous improvement to ensure patient safety and product excellence.

You will lead cross‑functional efforts with Engineering, Supply Chain, and Operations, reporting quality performance to site leadership and managing a team of QA professionals across levels.