This is an exciting new opportunity for a Quality Specialist to join a leading medical company based in Carlow. You will work within a small team that will be mainly responsible for compliance aspects within the Engineering team.
Key Duties & Responsibilities:
- Support Engineering activities through documentation generation, equipment and process investigations associated with GMP activities and completion of quality notifications.
- Be a document system expert; this will include document review, approval and document system work flow expedition.
- Raise CAPA's and conduct investigations.
- Assist in the management and/or assignment of Engineering training if required.
Experience
- Experience in Compliance systems such as IPI, SAP etc a distinct advantage.
- Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
- Report, standards, policy writing skills required.
- Proficiency in Microsoft Office and job related computer applications required.
- Lean Six Sigma Methodology experience desired.
- Experience working within an Engineering environment in a regulated industry a distinct advantage.
Qualifications
- Degree qualification or equivalent Min Level 7 (Science, Engineering, Technical).
For a confidential discussion and more information on the role, please contact Kevin Griffin
Kevin Griffin
kevin.griffin@collinsmcnicholas.ie
(021) 2427108