Quality Systems Engineer

My client, a Contract Medical Device Manufacturer in Kildare, is looking for a Quality Systems Engineer to join their team on a permanent basis.

The company are currently undergoing a significant expansion of their site.

The Quality Systems Engineer in this role will be responsible for supporting the Quality Manager, and working across the organisation to ensure internal system compliance and customer specifications are achieved.

This is an excellent opportunity for an experienced Quality Systems Specialist looking to take the next step in their career with a fast growing company, and gain exposure to multiple leading Medical Device clients

As Quality Systems Engineer, your responsibilities will include:

Own and manage the quality management system
Manage the internal audit program and supplier audit program.
Lead auditee for Regulatory, Customer and Corporate audits
Complaint trending and monitoring of corrective actions in order to drive continuous improvements.
Development, issuance and implementation of QA documentation.
Compile and execute validation protocols for the manufacturing processes and equipment of existing and new products. Ensure correct use of statistical QA methods into the production environment and provide technical resource for production team on relevant IQ/OQ/PQ protocol issues.
Manage site quality systems including CAPA, internal and supplier auditing and change control activities.
Delivering in-house training on quality assurance documents, concepts and tools.
Owner of batch release process in accordance with internal procedures.
Review and approval of site change control documents
Generate and monitor quality KPIsRequirements:

3rd level Qualification in Quality / Science / Engineering
5 years work experience in a Quality Engineering role in a highly regulated industry.If you are interested in this role, please submit your up to date CV here, or contact me directly for more info.

To find out more about Real please visit

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC(phone number removed) England and Wales
Leixlip, IE