Quality Compliance Engineer

AVD Appoint Ltd; Swansea; On-site; GBP 24,000 - 40,000; Full time

Job summary

AVD Appoint Ltd in Glamorgan is seeking a Quality Compliance Engineer to join a growing team specialising in highly regulated design, development and manufacture of advanced products. The role focuses on ensuring adherence to ISO 13485 and maintaining audit readiness.

You will lead internal audits (60%), host external audits for customers and cert bodies (30%), and drive CAPA actions through root cause analysis to support continual improvement.

Qualifications

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

Responsibilities

• Conduct internal audits in line with ISO 13485, occupying ~60% of time and coordinating audit schedules.
• Host external audits for customers or certification bodies, occupying ~30% of time.
• Prepare non-conformance reports (NCRs) and perform root cause analysis (RCA) with corrective and preventive actions (CAPAs).

Skills

Quality Compliance

Auditing

Regulatory Knowledge

Job description

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

I am currently recruiting for a Quality Compliance 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 Compliance Engineer on a permanent basis.

In this role as a Quality Compliance 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 Compliance 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

This is a fantastic opportunity for a Quality Compliance Engineer to work for a growing company who are working with some of the most advanced technology available. With the ambitious, but realistic plans the company has forecast there will be lots of opportunities to develop and progress internally if this appeals.

This is an immediate requirement so if you have the required skills and experience