QA Engineer Digital Systems

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

Meet the team:

As a QA Engineer, you will play an integral role in ensuring the quality of site processes and digital manufacturing to Dexcom standards. This crucial position supports Dexcom's exciting growth trajectory in delivering essential, life-changing products to our customers. As part of this dynamic and highly effective team, you will work closely across multiple functions, gaining broad exposure to our entire product life cycle.

Where you come in:

• You will work on the compliance and validation of manufacturing and digital systems exposure.


• You will contribute to the development and use of standardized validation templates and practices, while support validation activities for digital manufacturing systems, including MES.


• You will apply risk-based validation principles to system implementation and changes for digital manufacturing systems.


• You will be involved in planning, managing and prioritizing tasks/projects, tracking progress towards the overall goals and provide periodic updates to management.


• You will be responsible for OOS events, CAPAs, NCMRs and Change Order; establishing and maintaining communication to key stakeholders, reporting, investigation, disposition and the corrective action process.


• You will support the integration of new regulations or QMS standards by conducting gap assessments, recommending updates, and driving documentation revisions.


• You will support ongoing improvement and maintenance of the QMS to enhance operational efficiency, compliance, and product quality.


• You will support external inspections by regulatory bodies and notified parties. Ensure audit findings are addressed and closed effectively. Prepare quality system documentation and records for internal and external audits/ inspections.


• You may perform other duties as assigned.

What makes you successful:

• You have experience with CAPA, Non-Conformance, and problem-solving tools.


• You have experience working in digital systems is preferred


• You have experience participating in continuous improvement initiatives.


• You have proficiency in Microsoft Office and database applications (e.g., Excel and MiniTab or similar).


• You have strong critical thinking, decision-making, and problem-solving skills.


• You posses excellent written and oral communication and presentation skills.

Experience and Education Requirements:

• 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.


• You have experience in Quality in a medical device or related industry manufacturing environment.

What you'll get:

• A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.


• A full and comprehensive benefits program.


• Growth opportunities on a global scale.


• Access to career development through in-house learning programs and/or qualified tuition reimbursement.


• An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.