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
#LI-DB4
#J-18808-Ljbffr