Quality Engineer

About the Company

A global technology‑led manufacturing organisation specialising in high‑precision engineered products for regulated, quality‑critical sectors. With operations built on the foundations of ISO 9001 and ISO 13485, the company is committed to innovation, operational excellence, and continuous improvement.

About the Role

We are seeking a proactive and detail‑focused Quality Engineer to join a dynamic and fast‑paced operations environment. In this role, you will help ensure all products meet rigorous quality, safety, and regulatory standards. You will lead structured root‑cause investigations, drive defect‑prevention programmes, and support new product introduction activities while working closely with teams across Production, Engineering, and Supply Chain.

Key Responsibilities

• Resolve customer‑reported product quality issues by identifying root causes and implementing robust corrective actions.
• Ensure quality processes align with ISO 9001, ISO 13485, and internal Quality Management System (QMS) requirements.
• Leadproblem‑solving sessions using:
  • 8D methodology
  • 5 Whys
  • Fishbone / Ishikawa diagrams
  • FMEA
  • SPC
• Work collaboratively with cross‑functional teams to improve manufacturing quality and strengthen process capability.
• Maintain and analyse the Quality Dashboard, including KPIs such as Defects Per Unit.
• Support Lean and continuous‑improvement activities to enhance operational performance.
• Assist with new product introductions by ensuring process robustness and production readiness.
• Review and approve engineering changes to protect product quality and compliance.

What You'll Bring

• A relevant STEM degree or equivalent technical experience.
• Experience in a manufacturing or production‑based environment.
• Strong understanding of Lean principles and process optimisation.
• Advanced experience with structured problem‑solving, particularly 8D methodology.
• Beneficial: knowledge of life‑sciences/medical‑device manufacturing (ISO 13485 environments).
• Strong analytical skills, including proficiency with Excel, Pivot Tables, and Pareto analysis.
• Excellent communication skills and the ability to influence across diverse teams.
• Experience with tools such as 5 Whys and Fishbone Diagrams.