Senior QA Manager: Quality Systems & Regulatory Compliance

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

Benefits offered by this job

Benefits program

Growth opportunities

Tuition reimbursement

Job summary

Dexcom Ireland is seeking a Senior QA Manager to lead the European manufacturing site quality program in Athenry. You will oversee the quality system, audits, CAPA, and document control to ensure compliance with FDA and ISO requirements.

You will bring 13+ years of industry experience and 5-8 years of leadership to drive continuous improvement across manufacturing processes and QA programs, partnering with cross-functional teams to deliver robust quality outcomes.

Qualifications

• Typically requires a bachelor's degree in a technical discipline with 13+ years of industry experience and 5-8 years of previous people management experience.
• Experience with MDSAP/ISO13485/FDA21CFR820(QMSR).
• Experience handling Back/Front rooms in audits.
• Knowledge of Six Sigma, Lean manufacturing, sampling plans and other statistical modelling.
• Ability to develop systems and processes that improve product safety, increase conformance, and reduce costs.

Responsibilities

• Lead quality system compliance and document control.
• Manage audits and non-conformance related to product and processes.
• Lead management review for the site.
• Lead and manage audit readiness for the site.
• Coordinate cross-functional improvements and investigations.

Skills

QMS knowledge

Audit management

Statistical methods

Process improvement

People management

Education

Bachelor's degree in a technical discipline

Tools

Six Sigma

Lean manufacturing

Sampling plans

Statistical modelling

Job description

Dexcom Ireland is seeking a Senior QA Manager to lead the European manufacturing site quality program in Athenry. You will oversee the quality system, audits, CAPA, and document control to ensure compliance with FDA and ISO requirements.

You will bring 13+ years of industry experience and 5-8 years of leadership to drive continuous improvement across manufacturing processes and QA programs, partnering with cross-functional teams to deliver robust quality outcomes.