Software Validation Engineer II — CSV & 21 CFR Part 11

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

Job summary

Dexcom is recruiting a QA Engineer II – Software Systems in Athenry, Ireland to support compliance of computerised systems and manufacturing software with regulatory requirements. You will partner with IT, Manufacturing, Validation, and Regulatory Affairs to ensure validated, inspection-ready software systems across the organization.

The role requires 3+ years in a regulated environment, strong knowledge of 21 CFR Part 11, CSV, data integrity, and experience in software lifecycle processes.

Qualifications

• Bachelor’s degree in engineering, Quality, or related field.
• 3+ years of experience in a regulated industry.
• Knowledge of ISO 13485, 21 CFR Part 11, 21 CFR 820.
• Experience with software validation and CSV processes.

Responsibilities

• Act as software validation lead across manufacturing and quality operations.
• Review and approve CSV deliverables (URS, FS, IQ/OQ/PQ, etc.).
• Support audits and CAPA activities related to software systems.
• Provide guidance on software lifecycle and data integrity practices.

Skills

21 CFR Part 11

CSV (Software Validation)

Data integrity

Software lifecycle

Analytical thinking

Education

Bachelor's degree in engineering, Quality, or related field

Tools

MES

ERP

QMS

SQL (read-only queries)

Job description

Dexcom is recruiting a QA Engineer II – Software Systems in Athenry, Ireland to support compliance of computerised systems and manufacturing software with regulatory requirements. You will partner with IT, Manufacturing, Validation, and Regulatory Affairs to ensure validated, inspection-ready software systems across the organization.

The role requires 3+ years in a regulated environment, strong knowledge of 21 CFR Part 11, CSV, data integrity, and experience in software lifecycle processes.