Senior Quality Assurance Engineer

3 weeks ago

Cork, Cork, Ireland Cpl Full time
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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