Senior QA Systems Manager – FDA/ISO Compliance

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

Benefits offered by this job

Benefits program

Global growth opportunities

In-house learning programs

Tuition reimbursement

Job summary

Dexcom Ireland in Athenry is seeking a Senior QA Manager to lead quality systems, ensure FDA/ISO compliance, and drive audit readiness across the European manufacturing site.

You will manage quality policies, CAPAs, internal/external audits, and cross‑functional collaboration to sustain product safety and conformance, with 13+ years of technical experience and 5–8 years of people leadership.

Qualifications

• Typically requires a bachelor's degree in a technical discipline with 13+ years of industry experience and 5–8 years of people management experience.
• Experience with MDSAP/ISO13485/FDA21CFR820(QMSR) and audits.

Responsibilities

• Support Quality System Compliance (Audit/CAPA/NCMR/Internal Audit/Management Review) and document control.
• Lead management review for the site and audit readiness.
• Design and maintain the quality system according to written policies and procedures.
• Provide quality guidance across departments and drive improvements in product safety and conformance.

Skills

Quality systems

Audit management

Regulatory compliance

Six Sigma

Lean manufacturing

Education

Bachelor's degree in a technical discipline

Job description

Dexcom Ireland in Athenry is seeking a Senior QA Manager to lead quality systems, ensure FDA/ISO compliance, and drive audit readiness across the European manufacturing site.

You will manage quality policies, CAPAs, internal/external audits, and cross‑functional collaboration to sustain product safety and conformance, with 13+ years of technical experience and 5–8 years of people leadership.