QA Engineer, Digital Systems: Quality & Compliance

Dexcom Inc.; Athenry; On-site; EUR 45,000 - 70,000; Full time

Benefits offered by this job

Benefits program

Global growth opportunities

Tuition reimbursement

Job summary

Dexcom Inc. is seeking a QA Engineer to ensure quality of site processes and digital manufacturing to Dexcom standards. You will collaborate across functions to support the product life cycle and help maintain a robust QMS.

You will lead validation activities for manufacturing systems including MES, manage CAPAs and OOS events, drive continuous improvement, and prepare documentation for internal and external audits.

Qualifications

• Typically requires a Bachelor's degree in a technical discipline and 2–5 years of related experience, or a Master's degree and 0–2 years of equivalent experience.
• Experience in Quality within a medical device or related industry manufacturing environment.
• Familiar with CAPA, Non-Conformance, and problem-solving tools.
• Experience with digital systems and continuous improvement initiatives is preferred.

Responsibilities

• Work on the compliance and validation of manufacturing and digital systems exposure.
• Develop and use standardized validation templates and practices; support validation activities for digital manufacturing systems including MES.
• Apply risk-based validation principles to system implementation and changes.
• Plan, manage and prioritize tasks/projects; track progress and report to management.
• Manage OOS events, CAPAs, NCMRs and Change Orders; communicate with stakeholders and drive corrective actions.
• Support integration of new regulations or QMS standards; conduct gap assessments and update documentation.
• Support ongoing improvement and maintenance of the QMS to enhance efficiency, compliance, and quality.
• Assist with external inspections; prepare quality system documentation for audits/inspections.
• Perform other duties as assigned.

Skills

CAPA

Non-Conformance

Problem-solving

Digital systems

Continuous improvement

Critical thinking

Communication skills

MS Office

Education

Bachelor's in technical field

Master's degree

Tools

Excel

MiniTab

Database applications

Job description

Dexcom Inc. is seeking a QA Engineer to ensure quality of site processes and digital manufacturing to Dexcom standards. You will collaborate across functions to support the product life cycle and help maintain a robust QMS.

You will lead validation activities for manufacturing systems including MES, manage CAPAs and OOS events, drive continuous improvement, and prepare documentation for internal and external audits.