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
1. Support quality and process engineering activities in both manufacturing and R&D
2. Own and lead CAPA investigations, root cause analysis, and corrective actions
3. Develop, update, and manage technical documentation (FMEAs, Control Plans, protocols, reports)
4. Drive risk management processes and quality planning for product development
5. Collaborate with engineers, QA, and cross-functional stakeholders on continuous improvement projects
6. Analyse data from production and quality systems to reduce scrap and address non-conformances
7. Work autonomously while contributing to a high-performing team of four QA engineers
8. Report directly to the Quality Manager – no direct line manager in day-to-day operations
What You'll Need
9. Level 7 or higher qualification in Engineering, Science, or related discipline
10. Minimum 4 years' experience in a senior QA or Quality Engineering role in a regulated setting
11. Proven experience with CAPA, technical writing, and project execution
12. Strong grasp of GMP and ISO quality systems
13. Exposure to Six Sigma or Lean methodologies is highly desirable
14. Comfortable working independently and driving quality outcomes
15. Ability to influence, plan, and follow through on cross-functional projects
Why Join?
16. Be part of a collaborative, solutions-driven quality team
17. Work on key projects with autonomy and ownership
18. Gain exposure across multiple departments and influence product outcomes
19. Competitive salary and benefits package
#LI-DB4