Senior QA Leader — Quality Systems & Compliance

Dexcom Ireland - Athenry; Athenry; On-site; EUR 109,000 - 141,000; Full time

Benefits offered by this job

Benefits program

Global growth opportunities

Career development programs

Job summary

Dexcom Ireland is seeking a Senior QA Manager to lead development and implementation of quality policies and programs at our European manufacturing site in Athenry. You will ensure systems comply with FDA and ISO quality system regulations and manage audits and non-conformances.

The role requires 13+ years in the industry with 5–8 years of people management, a technical bachelor’s degree, and deep experience in regulatory affairs, quality systems, and continuous improvement.

Qualifications

• Experience with MDSAP/ISO13485/FDA21CFR820 (QMSR).
• Managed back/front rooms in external/internal audits.
• Reviewed data on product defects, response plans, dispositions; drove improvements.
• Knowledge of Six Sigma, lean manufacturing, sampling plans, statistical modelling.
• Developed systems and processes to improve safety, conformance, efficiency, and cost.

Responsibilities

• Support Quality System Compliance projects and objectives (Audit/CAPA/NCMR/Internal Audit/Management Review).
• Serve as a tactical decision-maker for regulatory interactions and conformance to requirements.
• Lead the Quality Department's objectives, plan, and cross-functional communication.
• Oversee audits, non-conformances, and management review for the site.
• Provide quality guidance to other departments and drive process improvements.

Skills

QA management

Regulatory compliance

Six Sigma

Lean manufacturing

Data analysis

Auditing

Education

Bachelor's degree in technical discipline

Tools

FDA CFR knowledge

ISO13485

Job description

Dexcom Ireland is seeking a Senior QA Manager to lead development and implementation of quality policies and programs at our European manufacturing site in Athenry. You will ensure systems comply with FDA and ISO quality system regulations and manage audits and non-conformances.

The role requires 13+ years in the industry with 5–8 years of people management, a technical bachelor’s degree, and deep experience in regulatory affairs, quality systems, and continuous improvement.