Quality Software Validation Engineer II

Dexcom Inc.; Athenry; On-site; EUR 65,000 - 90,000; Full time

Job summary

Dexcom Inc. is seeking a Quality Engineer II – Software Systems in Ireland to support the Quality Management System for regulated software and computerized systems. You will ensure CSV/CSA compliance, participate in validation activities, and guide lifecycle processes across manufacturing and quality teams.

You will interact with IT, Regulatory Affairs, Validation, and Manufacturing to ensure inspections readiness and continuous improvement in a compliant environment.

Qualifications

• Bachelor’s degree in engineering, Quality, or related field.
• Minimum 3 years of experience in a regulated industry.
• Knowledge of ISO 13485, 21 CFR Part 11, 21 CFR 820.
• Experience with manufacturing systems, MES, ERP, or QMS applications.
• SQL experience for read-only queries.
• Audit experience with FDA, BSI, or MDSAP.
• Experience working on cross-site or global system projects.
• Experience mentoring or training other engineers.

Responsibilities

• Serve as the Quality representative for software systems and CSV activities across manufacturing and quality operations.
• Ensure robust software validation practices are applied and documented per regulatory requirements.
• Review and approve all deliverables related to Software Validation (URS, IQ/OQ/PQ, Validation Reports).
• Provide guidance on Software Lifecycle processes for multiple systems.
• Ensure new/updated software systems are assessed and qualified per Change Control.
• Support software-related nonconformance events, investigations, and CAPA activities.
• Collaborate with Global Quality, IT, Manufacturing, Regulatory Affairs, and Validation teams.
• Support audits and external inspections (FDA, ISO 13485, BSI, MDSAP).

Skills

CSV/CSA principles

21 CFR Part 11

Cross-site projects

SQL read-only queries

Audit experience (FDA/BSI/MDSAP)

ISO 13485 knowledge

Education

Bachelor’s degree in engineering/Quality/related field

Tools

MES

ERP

QMS

Job description

Dexcom Inc. is seeking a Quality Engineer II – Software Systems in Ireland to support the Quality Management System for regulated software and computerized systems. You will ensure CSV/CSA compliance, participate in validation activities, and guide lifecycle processes across manufacturing and quality teams.

You will interact with IT, Regulatory Affairs, Validation, and Manufacturing to ensure inspections readiness and continuous improvement in a compliant environment.