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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