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
* Provide Quality and Process Engineering support across manufacturing and R&D projects
* Collaborate with cross-functional teams (R&D, Operations, Quality) to drive quality initiatives
* Lead and support investigations, root cause analysis, and CAPA implementation
* Develop and maintain product and process risk documentation (FMEAs, Control Plans)
* Contribute to quality planning for new product development
* Identify and mitigate manufacturing process issues (scrap, non-conformances, complaints)
* Prepare and track project plans, schedules, and budgets
* Influence continuous improvement initiatives and compliance enhancements
What You’ll Need
* Level 7 qualification (or higher) in Engineering, Science or related discipline
* Minimum 4 years' experience in a regulated manufacturing environment
* Strong understanding of Quality Systems and regulatory compliance (GMP/ISO13485)
* Hands-on experience with risk management tools and problem-solving techniques
* Ability to analyse data and make informed quality decisions
* Comfortable working independently and leading project teams when needed
* Experience mentoring junior team members is a plus
Why Join?
* Work in a high-performing team focused on innovation and quality
* Take on real responsibility with visibility across operations and development
* Be part of a company where quality isn’t just compliance – it’s culture
* Competitive salary and benefits package offered
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