Quality Projects Engineer required to join a market leading medical device organisation based in Galway. You should have prior experience working in a highly regulated medical device or pharmaceutical environment.
- Demonstrates commitment to the Quality Policy through the daily execution of sound quality practices.
- Leads quality related projects within the Device Manufacturing Value Stream.
- Supports CIP and NRE activities within the value stream.
- Provides quality support for the transfer of new product into device manufacturing.
- Provides additional support to the operations team when a new product is introduced.
- Completion of TAP analysis for new products.
- Supports validation activities within the value stream.
- Supports the approval of supplier change notifications.
- Supports audits for the value stream from external regulatory agencies.
- Updates quality procedures, specs as required.
- Provides root cause analysis & problem-solving guidance.
- BSc. in Science, Engineering or related.
- 5+ years supplier quality / quality operations experience in GMP manufacturing environment in Medical Device/Pharma industry.
- Project management experience.
- Good working knowledge of validation processes.
- Ability to work as a team member.
- Demonstrated the ability to lead in a previous role.
- Good organization and investigation skills are required.
- A Green Belt qualification advantageous.
- Excellent “hands-on” technical skills.
- Must be authorised to work in Ireland.
Please contact Emer Smith to discuss in confidence