Sr Quality & Validation Engineer (Software)

Sr Quality & Validation Engineer (Software)

Dexcom

Athenry, Ireland

Meet the team:

The Senior Quality & Validation Engineer (Software) is responsible for leading software validation strategy, lifecycle governance, and compliance for enterprise, manufacturing, and nonproduct systems. The role provides expert guidance on validation approaches, regulatory requirements, data integrity, and quality documentation while partnering with Software Systems Engineering, IT/OT, R&D, and cross functional teams.

The role requires strong knowledge of software lifecycle principles, GxP system expectations, and medical device regulatory requirements including ISO 13485, 21 CFR Part 11, 21 CFR 820, and MDSAP.

Where you come in:

• Lead the development of validation strategies for enterprise, manufacturing, and nonproduct systems;
• Serve as a subject matter expert for software validation and data integrity;
• Act as the senior Quality representative for site and cross site software initiatives. Mentor and support junior and midlevel Quality Engineers;
• Have a mastery level understanding of the Software Development Life Cycle (SDLC);
• Review and approve lifecycle documentation including SRS, SDS, SCS, validation protocols, reports, and risk assessments;
• Oversee validation deliverables including test plans, test scripts, traceability matrices, and verification evidence;
• Prepare and lead software documentation for internal audits, BSI audits, MDSAP audits, and FDA inspections;
• Lead impact assessments, risk evaluations, and compliance reviews for software changes and deviations;
• Use SQL to extract read only data for investigations, troubleshooting, and audit evidence;
• Drive continuous improvements, including template updates, workflow optimization, and cross site harmonization;
• Additional quality responsibilities as assigned.

What makes you successful:

• Demonstrated expertise in software validation principles, regulatory expectations, and industry best practices;
• Strong ability to influence and guide cross‑functional teams;
• Advanced skills in documentation review, compliance assessment, and quality governance;
• Exceptional attention to detail with a disciplined approach to evidence of integrity and record accuracy;
• Proven analytical ability to assess complex issues and apply structured, effective problem‑solving;
• Strong organisational skills with the ability to manage multiple priorities and deliver under tight timelines;
• Excellent communication skills, enabling clear and effective engagement with both technical and non‑technical stakeholders.

Experience and Education Requirements:

• Bachelor’s degree in Engineering, Computer Science, Quality, or related field;
• At least five years of experience in software validation or computer system validation in a regulated industry;
• Strong understanding of GAMP 5, software lifecycle models, and risk based validation;
• Knowledge of ISO 13485, 21 CFR Part 11, 21 CFR 820, and data integrity principles;
• Experience leading validation of complex systems - MES and Manufacturing Databases;
• Experience working on cross site or global system projects;
• Audit experience with FDA, BSI, or MDSAP;
• SQL experience for read only queries.