NPI Quality Engineer
An new permanent opportubity for a NPI Quality Engineer had come available with one of our medical devices clients in Sligo.
The successful client will work within a cross functional team involved in the setup, manufacturing and supply of products to the company's established customer base.
Other duties include:
- Support the Quality Engineering elements of related processes, updating and improving the Quality Management System as required.
- Maintain the Quality Notification process for the management of CAPA, vendor CAPA, MRB, Customer Complaints, and similar related activities.
- Work very close with the Validation Function within the site to ensure complete transparency and accuracy of validation & verification documentation generated in support of the new product introduction approval effort.
- Work cross functionally with all affected departments to ensure the quality engineering elements of the project are clearly understood, and team members clearly understand the requirements to be met.
* Bachelor's degree in Quality Management/ Quality Assurance / Engineering or equivalent industry experience
* 2 years' experience in a similar role in the Medical Device Industry.
* Knowledge of ISO, MDD, FDA requirements essential
* Knowledge of Quality Standards, Validation Regulations and Guidance Documents required
* MS Office proficient. Experience with SAP beneficial.
* Proven track record in a similar role.
* Strong project management capabilities.
* Excellent attention to detail in oral & written communication, with a proven technical protocol & report writing background
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