about 1 year ago
QA Specialist in Dublin or Galway
My client, a Life Science Startup setting up its business in Ireland, is looking for a QA Specialist either in Dublin or Galway. The position is part-time for an initial period of 12 months with the possibility of evolving into a full-time permanent employment after 12 months, subject to obtaining the ISO 13485 and the CE Marking of the products. You think this might be you? Keep reading!
You will be responsible for:
- Establishing and maintaining the necessary documentation for the ISO 13485
- Setting up and maintaining the QMS
- Working closely with the external consultant on the CE Marking of the new products
- Maintaining a close working relationship with Regulators and the Notified Body
- Engineering/Science qualification
- 5 years of working experience within a medical device environment in a similar capacity
- Knowledge of Quality and Regulatory requirements and regulations including but not limited to ISO 13485 Quality system requirements, Council Directive 93/42/EEC (Medical Device Directive), MEDDEV
- Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook and Excel)
- Excellent technical writing experience within a medical device environment
- Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience.
The next step for you:?
Should this position be of interest to you please forward your CV to?Simona Morelli from?Next Generation Recruitment?or alternatively call on the main line on??+353 16498537. Next Generation are specialists in Engineering, Data Science, Digital, Finance, IT Contract, IT Permanent, Life Sciences, Supply Chain, Procurement & Operations. Applications are in strict confidence. Next Generation will never share your data outside of our organisation without your prior written consent. All our calls are recorded for training and monitoring purpose. Please read our Data Protection Policy on our website.