Senior Quality Assurance Engineer New
CPL Tipperary
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
- 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
- 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
OrnuaMitchelstown, 24 km from Tipperary
Path to Prosper’ strategy. We have delivered significant growth in our core business, and we have ambitious plans for continued growth over the next five years.
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