Senior Quality Compliance Manager

1 DexCom Inc; Colorado; On-site; USD 111,000 - 185,000; Full time

Benefits offered by this job

Comprehensive benefits

Career development programs

Tuition reimbursement

Job summary

Dexcom Corporation is seeking a seasoned Quality Assurance leader to manage site Document Control within the QMS, ensuring compliance with FDA and ISO standards while driving continuous improvement across quality systems. You will lead audits, CAPA activities, and metrics reporting to senior management.

Ideal candidates will have strong technical writing skills, experience in risk-based decision making, and the ability to influence cross-functionally in a fast-paced medical device environment.

Qualifications

• Knowledge of FDA 21 CFR 820 and ISO 13485.
• Strong writing and documentation skills.
• Experience leading quality-system improvements.
• Ability to manage audits and CAPA processes.

Responsibilities

• Oversee site Document Control within QMS.
• Lead internal/external audits and remediation.
• Develop compliance metrics for leadership reviews.
• Drive CAPA closure and quality records.

Skills

Regulatory compliance

Quality leadership

Audits & CAPA

Risk-based decision making

Technical writing

Education

Bachelor's degree

Tools

5 Whys

Fishbone diagram

FMEA

DOE

Job description

Dexcom Corporation is seeking a seasoned Quality Assurance leader to manage site Document Control within the QMS, ensuring compliance with FDA and ISO standards while driving continuous improvement across quality systems. You will lead audits, CAPA activities, and metrics reporting to senior management.

Ideal candidates will have strong technical writing skills, experience in risk-based decision making, and the ability to influence cross-functionally in a fast-paced medical device environment.