Senior Quality Compliance Leader (FDA/ISO)

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

Benefits offered by this job

Comprehensive benefits

Career development

Tuition reimbursement

Job summary

Dexcom is seeking a seasoned QA leader to oversee the site Document Control team within the Quality Management System (QMS) and ensure regulatory compliance with FDA and ISO standards. You will drive audits, CAPAs, and quality improvements across cross-functional teams.

The role emphasizes risk-based decisions, data-driven metrics, and strong technical writing to support product excellence and patient safety in a fast-paced environment.

Qualifications

• Knowledge of FDA 21 CFR 820 and ISO 13485.
• Proven ability to lead cross-functional teams.
• Strong technical writing for quality documentation.
• Experience with audits, CAPAs, and compliance risk management.

Responsibilities

• Oversee site Document Control within the Quality Management System (QMS).
• Ensure compliance with ISO 13485, FDA and other standards.
• Lead internal and external audits and remediation activities.
• Manage CAPAs, MRB, and quality metrics reporting to site leadership.

Skills

FDA knowledge

ISO 13485

CAPA management

Regulatory communication

Education

Bachelor's degree

Tools

5 Whys

Fishbone

FMEA

DOE

Job description

Dexcom is seeking a seasoned QA leader to oversee the site Document Control team within the Quality Management System (QMS) and ensure regulatory compliance with FDA and ISO standards. You will drive audits, CAPAs, and quality improvements across cross-functional teams.

The role emphasizes risk-based decisions, data-driven metrics, and strong technical writing to support product excellence and patient safety in a fast-paced environment.