A medical device start-up in Galway have been recently acquired by an international pharmaceutical company. With Galway being home to their R&D center, they're going through an exciting phase for vascular technologies product development and to increase headcount this year.
We are looking for a Quality Systems Engineer or someone working in a highly comparable role in the medical device industry (including working in quality sytems) and is motivated to move into a senior position in a start-up. A degree in science/engineering/quality is needed - level 7 or level 8.
As Senior Quality Systems Engineer, the purpose of your role is to develop, implement and manage quality systems, which ensure that the company's activities are performed in a manner that assures product quality and meets regulatory requirements.
Some of your day-to-day will include:
- Manage the field complaints handling system.
- Manage the CAPA system.
- Manage the Audit system.
- Manage the document control center and mentor the DCC personnel.
- Manage the Management Review process.
- Monitor medical device regulatory requirements to ensure that the company's quality management system is compliant at all times.
- Lead the activities associated with preparing the company's QMS to achieve and maintain certification to ISO, FDA and PMDA regulations as well as the upcoming MDR requirements.
- Coordinate activities in the preparation and management of audits by regulatory bodies.
Apply with you current CV for consideration of contact Roisin Finneran for more. *EU Passport/Stamp 4 Visa needed.
To find out more about Real please visit www.realstaffing.com
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 | OC387148 England and Wales