Senior Quality Assurance Engineer

7 days ago

Nenagh, County Tipperary, Ireland Cpl Full time

Senior Quality Assurance Engineer

Clonmel, Co. Tipperary

Full-time |

Onsite 4 days onsite 1 day WFH

Permanent

A leading medical device manufacturer in Clonmel is hiring a Senior Quality Assurance Engineer to join their Quality Assurance Project Team. This is a hands-on role supporting high-impact quality projects across manufacturing and R&D, with a strong focus on CAPA, technical writing, and continuous improvement.

What You'll Be Doing

Support quality and process engineering activities in both manufacturing and R&DOwn and lead CAPA investigations, root cause analysis, and corrective actionsDevelop, update, and manage technical documentation (FMEAs, Control Plans, protocols, reports)Drive risk management processes and quality planning for product developmentCollaborate with engineers, QA, and cross-functional stakeholders on continuous improvement projectsAnalyse data from production and quality systems to reduce scrap and address non-conformancesWork autonomously while contributing to a high-performing team of four QA engineersReport directly to the Quality Manager – no direct line manager in day-to-day operations

What You'll Need

Level 7 or higher qualification in Engineering, Science, or related disciplineMinimum 4 years' experience in a senior QA or Quality Engineering role in a regulated settingProven experience with CAPA, technical writing, and project executionStrong grasp of GMP and ISO quality systemsExposure to Six Sigma or Lean methodologies is highly desirableComfortable working independently and driving quality outcomesAbility to influence, plan, and follow through on cross-functional projects

Why Join?

Be part of a collaborative, solutions-driven quality teamWork on key projects with autonomy and ownershipGain exposure across multiple departments and influence product outcomesCompetitive salary and benefits package

#LI-DB4

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