We’re currently recruiting for an exciting opportunity with a Medical Device organization based in Galway. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Duties
1. Work with Key Stakeholders to lean the current QMS to achieve an efficient QMS
2. Work closely with the notified body to successfully obtain ISO13485 certification
3. Ensure that the necessary updates are communicated to the competent authority, regulatory bodies and customers as changes arise
4. Work with Regulatory Affairs to provide documentation to external customers to support their submissions
5. Support Notified Body / Regulatory Agency / Customer Audits
6. Perform Internal and Supplier Audits
7. Manage the tracking of the Corrective / Preventive Management Process, working closely to support CAPA leads to successfully implement effective CAPA
8. Manage the tracking of the Non-Conformance Process, working closely with NCR action owners to ensure timely closure of Non-conformances
Education & Experience
9. Minimum of level 8 degree in related field
10. Experience in medical device or other highly regulated industry
If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or sean.mccarthy@lifescience.ie for further information.