Our Galway based client are looking to hire a VP of QARA to help guide and grow their QARA team as they continue to expand in size of company and product range.
Purpose of the role:
· To manage and maintain the Quality Management System and the Operational Quality Requirements.
A portion of the responsibilities for this role:
- Ensuring that processes needed for the Quality Management System are established, implemented and maintained
- Ensuring the promotion of awareness of regulatory and customer requirements throughout the organization
- Liaison with External parties on matters relating to the Quality Management System
- Responsible for the development and implementation of the Corrective and Preventative (CAPA) actions and Audit Systems
- Management of Design History Files, Technical Files, Design Dossiers; PMA and 510k submissions to Notified Bodies, FDA and Competent Authorities
- Fostering a strong, interactive and results-driven work environment for the team.
- Management experience of medical device QMS activities
- Clinical Research experience of Class III devices
- Experience of Regulatory submissions for Class III devices
For a full job description and more information on this role please contact Chris O Toole for a confidential discussion.