Senior Quality Assurance Engineer

2 weeks ago

Cork, Cork, Ireland Cpl Healthcare Full time

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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