Quality Engineer

Location: Leeds ICD

Customer Quality Engineer / Medical equipment precision engineering company / Leeds area / Circa £45,000 + benefits

Our Client

Is a successful precision engineering company based in the Leeds, West Yorkshire area. They have a fine heritage of producing the highest quality precision metal components into cutting edge industries.

The Role

We are seeking an experienced and customer-focused Quality Engineer. This role is heavily quality assurance focused, with a strong emphasis on customer relationship management, complaint handling, and continuous improvement across Class I, II, and III medical device manufacturing operations.
The successful candidate will work closely with customers, manufacturing, engineering, and quality teams to ensure compliance with regulatory requirements, customer expectations, and internal quality standards.

The Person

Proven experience in a Quality Engineering or Quality Assurance role within the medical device industry.

* Strong understanding of medical device manufacturing environments, ideally across Class I, II, and III devices.

* Good knowledge of ISO 13485, EU MDR, FDA regulations, and medical device compliance requirements.

* Hands-on experience managing:

* Customer complaints

* Non-Conformances (NCs)

* CAPA systems

* Root Cause Analysis (RCA)

* Quality Management Systems (QMS)