QA Engineer Digitial Systems
On-siteAthenry, Connacht, Ireland
Job Summary
Conduct risk-based validation for digital manufacturing systems, including MES, and apply standardized validation templates to system implementations. Manage and prioritize tasks for quality assurance projects, tracking progress and reporting to management. Investigate OOS events, CAPAs, NCMRs, and Change Orders, establishing communication with stakeholders to drive corrective actions and dispositions. Prepare quality system documentation for internal and external audits, ensuring audit findings are addressed and closed effectively. Support regulatory inspections by notified parties and assist in integrating new regulations or QMS standards through gap assessments and documentation revisions.
Required Qualifications
- Bachelor's degree in a technical discipline
- 2–5 years of related experience
- Master's degree and 0–2 years of equivalent experience
- Experience in Quality in a medical device or related industry manufacturing environment
- Experience with CAPA
- Experience with Non-Conformance
- Experience with problem-solving tools
- Experience in digital systems
Desired Qualifications
- Experience participating in continuous improvement initiatives
- Proficiency in Microsoft Office and database applications (e.g., Excel and MiniTab or similar)
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