Senior QA Manager: Compliance & Quality Systems

Dexcom Inc.; Athenry; On-site; EUR 110,000 - 160,000; Full time

Benefits offered by this job

Comprehensive benefits program

Career development opportunities

Global growth opportunities

Job summary

Dexcom Inc. in Ireland (Athenry) seeks a Senior QA Manager to drive quality policy development and program implementation. You will ensure compliance with FDA and ISO quality system regulations, guiding cross‑functional teams in a high‑volume manufacturing setting.

You will lead audits, manage nonconformances, and oversee document control while shaping quality culture and improving product safety and conformance to requirements on a global scale.

Qualifications

• Experience with MDSAP/ISO13485 and FDA 21 CFR 820(QMSR).
• Experience leading internal and external audits (Back/Front rooms).
• Knowledge of Six Sigma, lean manufacturing, sampling plans and statistical modelling.

Responsibilities

• Provide support for Quality System Compliance projects and document control.
• Lead regulatory compliance and conformance activities across the site.
• Manage quality systems design, implementation, and cross‑functional guidance.
• Oversee operational management in high‑volume manufacturing environments.
• Lead site management review and audit readiness activities.

Skills

MDSAP/ISO13485/FDA21CFR820(QMSR)

Audit management

Quality system development

Regulatory guidance

Six Sigma / Lean manufacturing

Data review & analysis

Process improvement

Education

Bachelor's degree in a technical discipline

Job description

Dexcom Inc. in Ireland (Athenry) seeks a Senior QA Manager to drive quality policy development and program implementation. You will ensure compliance with FDA and ISO quality system regulations, guiding cross‑functional teams in a high‑volume manufacturing setting.

You will lead audits, manage nonconformances, and oversee document control while shaping quality culture and improving product safety and conformance to requirements on a global scale.