Quality Engineer

About the role

We are looking for a Quality Engineer to support and continuously improve our Quality Management System (QMS) within a high‑volume production environment. You will ensure compliance with ISO 13485, ISO 14001, GMP and related standards while working closely with customers and internal teams on new product introductions and quality issues.

Key responsibilities

• Support and enhance the QMS, maintaining compliance with ISO 13485, ISO 14001, GMP and EHS requirements.
• Collaborate with customers and internal teams on new product introductions, quality issues, process qualifications and validation activities.
• Develop and implement process controls, conduct quality engineering analyses and drive initiatives to prevent non‑conformances and reduce risk.
• Manage quality system processes including NCRs, CAPAs, internal audits, external audit support and quality training programs.
• Monitor, trend and analyse quality data, providing manufacturing quality support.

Required profile

• Third‑level qualification in Engineering, Polymer Science or a related discipline.
• At least 3 years of experience in a Quality Engineering or Quality Assurance role within medical devices, injection moulding or other regulated manufacturing environments.
• Proven experience with statistical analysis tools, SPC and process validation activities.

Required skills

• Minitab (statistical analysis tool)
• Statistical Process Control (SPC)
• Process validation activities
• Knowledge of ISO 13485, ISO 14001 and GMP standards