A Senior Design Assurance Engineer is urgently needed to join a team of highly talented professionals in a growing medical device company in Galway.
The company are well-recognised in their field and are located in the heart of Galway. They are dedicated to ensuring their team culture is as inclusive as possible, often organising team-building events for staff including holidays abroad. They are well-known for encouraging upskilling and training internally so this is a really good company to be a part of in order to build up your skillset and gain invaluable experience.
This is a full-time, permanent position working to a 40 hour week. You will be compensated with an extremely competitive salary (DOE) plus a yearly bonus.
What will I be doing as Senior Design Assurance Engineer?
As Senior Design Assurance Engineer, you will fulfil the company's quality assurance, design assurance & regulatory affairs responsibilities as part of the Quality team. You will be responsible for leading the key elements of the Design Review process, ensuring they are compliant with internal procedures including EU and FDA. You will also lead the risk management process and prepare risk management files. Working with research and development to establish design specifications and product requirements is another key aspect to the role.
To become a Senior Design Assurance Engineer, you will need to have a Bachelor's degree (Level 8) in engineering, biomedical or science. You are required to have at least 5 years' experience in a medical device manufacturing environment, with direct experience in a design assurance role. You will have knowledge and demonstrated practice of risk management methodologies as per EN ISO14971. Experience with involvement in Regulatory submissions would be an advantage.
Meet the above requirements? Think this is the job for you? If so, please apply directly for immediate consideration.
*EU passport/Stamp 4 Visa required.*
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