Senior Quality Assurance Engineer
Clonmel, Co. Tipperary | Full-time | Onsite | Permanent
A leading medical device manufacturer is seeking a Senior Quality Assurance Engineer to join its established Quality team in Clonmel. This role offers the opportunity to work on high-impact projects that directly influence patient safety and product quality in a regulated environment.
What You'll Be Doing
1. Provide Quality and Process Engineering support across manufacturing and R&D projects
2. Collaborate with cross-functional teams (R&D, Operations, Quality) to drive quality initiatives
3. Lead and support investigations, root cause analysis, and CAPA implementation
4. Develop and maintain product and process risk documentation (FMEAs, Control Plans)
5. Contribute to quality planning for new product development
6. Identify and mitigate manufacturing process issues (scrap, non-conformances, complaints)
7. Prepare and track project plans, schedules, and budgets
8. Influence continuous improvement initiatives and compliance enhancements
What You'll Need
9. Level 7 qualification (or higher) in Engineering, Science or related discipline
10. Minimum 4 years' experience in a regulated manufacturing environment
11. Strong understanding of Quality Systems and regulatory compliance (GMP/ISO)
12. Hands-on experience with risk management tools and problem-solving techniques
13. Ability to analyse data and make informed quality decisions
14. Comfortable working independently and leading project teams when needed
15. Experience mentoring junior team members is a plus
Why Join?
16. Work in a high-performing team focused on innovation and quality
17. Take on real responsibility with visibility across operations and development
18. Be part of a company where quality isn't just compliance – it's culture
19. Competitive salary and benefits package offered
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