Senior Quality Systems Engineer
Full time- Fixed Term (5 month Contract)
Galway- Hybrid
As a Senior Quality Systems Engineer at Veryan, you will have the opportunity to work alongside experienced professionals in a dynamic, collaborative environment, where you will play a key role in supporting meaningful and high-impact projects.
What You Will Do:
To ensure Veryan's Quality Management Systems (QMS) are compliant with the relevant directives and regulations you will be responsible for the following activities:
* To maintain the CAPA and Complaint Systems.
* To manage Quality Systems data collection and analysis.
* Prepare and present Monthly Quality Reports.
* Complete GAP assessments on Quality Management System regulations
* Support Software Validation activities
* Support the Management Review Process.
* Support the maintenance and continuous improvement of the QMS processes.
* Support other Quality system activities, e.g. Audit Management, SOP Updates, Document System Management.
What Do You Require:
* Educated at minimum to a Diploma Level in Engineering, Science or Quality Assurance discipline.
* A minimum of five years' relevant experience in the medical device or pharmaceutical industry.
* Familiarity of ISO13485, ISO14971, Medical Device Regulation 2017/745 and FDA QMSRs.
* Good communication and organisational skills, and the ability to present reports neatly and accurately.
* Training/Qualification in Quality Systems, Risk Management, Complaint CAPA management, Auditing and Medical Device regulations is highly desirable.
Benefits of Working with Veryan:
* Competitive salary and bonus.
* Pension scheme with generous employer contributions.
* Private medical insurance for you, spouse / partner and dependents.
* Paid sick leave & Group life cover.
* Hybrid working, and flexible start and finish times.
* Active Sports and Social Committee with a schedule of events taking place during the year.
* Opportunities for further education, training and development.
Our Company Values:
* Collaborative
* We respect one another, and work as a team toward a common goal.
* Innovative
* We are passionate and 'think big' with our innovations.
* Empowering
* We support and recognise the achievements of one another.
* Patient-Centric
* We are committed to excellence.
* Acting with Integrity
* We are transparent and do what is right.
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