Quality Engineer

Quality Engineering Support | Quality Engineer | Medical Device Quality Engineer

Cardiff, CF14 | £15-£20 per hour, depending on experience | Monday to Friday, days | 37.5 hours per week | Ongoing Temporary, with Potential to Become Permanent

Introduction

Acorn by Synergie is working with a market specialist in their field who is seeking a Quality Engineering Support professional to join their team in Cardiff on an ongoing temporary basis.

There is scope for the role to become permanent for the right candidate, in the right circumstances.

This opportunity would suit someone with practical Quality Engineering experience in a regulated medical device manufacturing environment, with a strong understanding of quality systems, nonconformance investigations, CAPA and equipment and process validation.

Working Hours & Pay

• Monday to Friday, regular day shifts.

• 37.5 hours per week.

• £15-£20 per hour, depending on experience.

Key Duties & Responsibilities

Depending on business priorities and individual experience, you will support activities including:

• Nonconformance, deviation and CAPA investigations, including structured root cause analysis and implementation of corrective actions.

• Manufacturing quality issue resolution and ongoing shop-floor Quality Engineering support.

• Equipment and process qualification and validation, including engineering studies and IQ/OQ/PQ activities.

• Development, execution and review of validation protocols and reports.

• Change control, engineering change reviews and quality impact assessments.

Key Requirements

Candidates should be able to demonstrate:

• Practical Quality Engineering experience within a regulated medical device manufacturing environment.

• Working knowledge of ISO 13485 and applicable medical device regulatory and Quality Management System (QMS) requirements.

• Strong experience with nonconformance investigations, root cause analysis and CAPA.

• Experience supporting or leading equipment and process qualification and validation, including IQ/OQ/PQ.

• Experience with change control and manufacturing/process risk management, including PFMEA.

Ideal Experience

The following experience would be beneficial:

• Medical device manufacturing Quality Engineering experience.

• Investigation, root cause analysis and CAPA experience.

• Equipment and process validation and IQ/OQ/PQ experience.

• PFMEA, risk management and change control experience.

• ISO 13485 and regulated QMS experience.

Interested?

To be considered for this Quality Engineering Support opportunity in Cardiff, please apply with your up-to-date CV.

Acorn by Synergie acts as an employment business for the supply of temporary workers.