Senior QA Manager, Quality Systems — Global CGM

Dexcom Inc.; Athenry; On-site; EUR 110,000 - 140,000; Full time

Benefits offered by this job

Comprehensive benefits

Global growth opportunities

Tuition reimbursement

Job summary

Dexcom in Athenry, Ireland, seeks a Senior QA Manager to lead the site’s quality systems, policies and regulatory compliance, ensuring alignment with FDA and ISO requirements and enabling scalable manufacturing.

You will drive audit readiness, CAPA and NCR programs, oversee management reviews, and mentor a growing team. The ideal candidate has 13+ years in technical QA and 5–8 years of people management, with MDSAP/ISO13485/FDA experience.

Qualifications

• Bachelor's degree in a technical discipline; 13+ years of industry experience.
• 5–8 years of people management experience.
• Experience with MDSAP/ISO13485/FDA 21 CFR 820 (QMSR).
• Leading internal and external audits; audit readiness.
• Knowledge of Six Sigma, lean manufacturing, sampling plans.

Responsibilities

• Develop and implement the quality policies and programs; lead Quality Systems.
• Ensure FDA and ISO regulatory compliance for quality systems.
• Lead audit readiness and manage CAPA/NCMR/Management Review.
• Oversee document control, audits, and cross-functional quality guidance.
• Drive process improvements to improve product quality and conformance.

Skills

MDSAP

ISO 13485

FDA 21 CFR 820

Quality systems

Auditing

Education

Bachelor's degree in technical discipline

Tools

Six Sigma

Lean manufacturing

Statistical sampling

Job description

Dexcom in Athenry, Ireland, seeks a Senior QA Manager to lead the site’s quality systems, policies and regulatory compliance, ensuring alignment with FDA and ISO requirements and enabling scalable manufacturing.

You will drive audit readiness, CAPA and NCR programs, oversee management reviews, and mentor a growing team. The ideal candidate has 13+ years in technical QA and 5–8 years of people management, with MDSAP/ISO13485/FDA experience.