Senior Quality Assurance Engineer New

• 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.

• 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

• 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

• 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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