Description
QA Engineer Exciting Projects and CAPA managementMy client is a leading mulitnational medical devices manufacturing company and they are looking to hire an experienced QA engineer with excellent project management skills and experience with CAPA's and new product introductions.
A key role of this position is to proactively support quality engineering activities with regards to product robustness changes and compliance related projects, ensuring technical correctness, and compliance with requirements of global regulations. This is an essential function in the overall strategy for improved assurance of delivered product quality and continuity of established QMS and to support growth of the Company.
The QA Engineer role will involve:
* Ensure Regulatory compliance in area of responsibility to cGMP's of all medical device regulatory agencies
* Drive and implement plant wide quality system improvements.
* Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
* Takes a leadership role in developing and implementing new techniques and initiatives to enhance the Quality management system on site and across the Corporation where relevant.
* CAPA Management, support Engineering and Manufacturing teams and lead CAPA investigations as required
* Collate and trend quality data relating to product robustness, conduct analysis and recommend necessary technical solutions to drive effective corrective action.
* Conduct detailed root cause analysis on design related non conformances, developing effective preventive measures to prevent recurrence.
* Approval of change requests for product, process and quality system changes.
* Key member of New Product Introduction teams, transfer and implement product and processes from development or from another manufacturing facility.
Experience required for the QA Engineer role:
* Engineer/Science qualification (Minimum BSc or BEng) with minimum of 3-5 years working in a similar QA role within QA/RA in a multi-national medical devices manufacturing environment
* Excellent working knowledge of ISO 13485 and 21CFR820, along with exposure to other regulations. Working familiarity with IEC 60601 a distinct advantage
* Experience with leading and participating in several projects concurrently.
* Ability to accurately scope projects and consider the full impact of decisions and actions taken.
* Strong Problem solving skills for developing creative solutions and meeting objectives are required.
* Experience in internal auditing to QSRs
An excellent salary of €50,000 is on offer. If you are interested in this QA Engineer position please contact me Adele Moran on for more information and for immediate consideration
To find out more about Real please visit www.realstaffing.com