Quality Engineer

Quality Engineer - Glamorgan - up to £40,000 + Relocation + Benefits - Ref 2030

I am currently recruiting for a Quality Engineer to work for a cutting-edge technology company based in Glamorgan. Salary up to £40,000 + Relocation + Benefits.

The organisation has been in operation for many years and are worldwide leaders within the design, development, and manufacture of their highly intelligent products. As a business they turnover close to £100 million, employ around 250 people and are constantly evolving their legacy products as well as designing and developing new innovative products to bring to market ensuring the maintain their position as market leaders.

In line with demand for their products and to support the business with their growth plans they have the need to appoint another Quality Engineer on a permanent basis.

In this role as a Quality Engineer, you will be responsible for the internal audits within the company inline with ISO:13485. This will occupy around 60% of your time and will involve you setting up the audit schedule and then owning it through the process raising any issues that arise to the necessary senior stakeholders within the business. 30% of your time will be spent hosting external audits for customers or certification companies coming onto site. The remainder of your time will be spent on creating non-conformance reports (NCR's) and then undergoing root cause analysis (RCA's) with a view of advising and agreeing on corrective and preventative actions (CAPA's).

Essential Requirements

• Previous experience as a Quality Engineer or similar
• At least 3 years' experience conducting audits in a highly regulated environment
• Experience with ISO:13485

Desirable Requirements

• EUMDR and/or MDSAP
• Experience with Engineering Change Requests
• Experience with CAPAs
• Understanding of UDI and GTIN