Senior Quality Assurance Engineer

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&D
• Own and lead CAPA investigations, root cause analysis, and corrective actions
• Develop, update, and manage technical documentation (FMEAs, Control Plans, protocols, reports)
• Drive risk management processes and quality planning for product development
• Collaborate with engineers, QA, and cross-functional stakeholders on continuous improvement projects
• Analyse data from production and quality systems to reduce scrap and address non-conformances
• Work autonomously while contributing to a high-performing team of four QA engineers
• Report 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 discipline
• Minimum 4 years’ experience in a senior QA or Quality Engineering role in a regulated setting
• Proven experience with CAPA, technical writing, and project execution
• Strong grasp of GMP and ISO 13485 quality systems
• Exposure to Six Sigma or Lean methodologies is highly desirable
• Comfortable working independently and driving quality outcomes
• Ability to influence, plan, and follow through on cross-functional projects

Why Join?

• Be part of a collaborative, solutions-driven quality team
• Work on key projects with autonomy and ownership
• Gain exposure across multiple departments and influence product outcomes
• Competitive salary and benefits package

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