Software Quality Assurance Engineer X 2

Description

Software Quality Assurance Engineer x 2 Medical Devices

My client is a leading Medical Devices company and they are seeking two Software Quality Assurance Engineers to join their expanding team. It is an exciting time for this company who are highly successful in the market and offer an excellent work environment where you will be working alongside highly talented people.

The Software Quality Assurance Engineer will act as a SQA lead on software or automation projects, conduct verification and validation activities for Shop Floor Information Systems and other computerised systems for use in the manufacturing and release of Medical Devices on a project basis.

What the Software Quality assurance role will involve:

QA & SQA Activities
Responsible for ensuring that systems are in compliance with regulatory commitments, in-house requirements and cGMPs in regards to computerised systems.
Investigation of software related deviations as part of quality team.
Review of software related GMP critical documents, eg Requirement documents, software validation protocols, change controls and discrepancy reports.
Participate in Software Process Improvement activities.
Manage the software corrective action process
Participate in requirements gathering

Validation Activities:
Review of pre-delivery or vendor supplied information in regards to suitability to proceed with validation activities.
Development of protocols, test scripts and associated support documentation
Overview of the execution of software related protocols
Responsible for managing the Corrective Action process in regards to individual validations to ensure follow-up and effective resolution.

Qualifications / Experience required:
Third level qualification in a science, engineering or computing discipline.
5+ years experience in a GMP regulated environment or software quality role.
Self motivated with ability to lead a core team to meet objectives.
Must be familiar with the regularoty requirements of the FDA and/or ISO
Decisive, good communicator, record of achievement and be a good team member.
Experience of executing validations in a cGMP manufacturing environment
Experience of scientific report writing including such documents as SOPs, protocols, deviations, reports etc. is essential

This role is a 12 month fixed term contract where you will gain excellent experience working in a leading global medical devices company. This role is based in Waterford with an excellent salary of €45,000 - €50,000.

If you are interested in this position please contact me Adele Moran on for more information and click apply now for immediate consideration.

To find out more about Real please visit www.realstaffing.com