We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Cork. 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.
1. Execution and project management responsibility for packaging aspects of the semi-automated line
2. Manage risk management and validation lifecycle for the packaging process change.
3. Execution of the validation requirements for new process (Change Controls, IQ/ OQ/PQ).
4. Conduct DOEs and Engineering Studies to ensure compliance
5. Direct PFMEA studies and lead risk assessment effort for overall process.
6. Influence innovative qualification methodologies to apply appropriate statistical and validation techniques based on failure model and overall risk
7. Design, develop and source tools, fixtures and special equipment for pack processes. Co-ordinate with internal and external partners.
8. Planning of key deliverables into action plans & provide timely and accurate reporting on project activities.
9. Represent the Operations team on product development projects, communicating requirements and proposing solutions.
Education & Experience
1. A minimum of a Bachelor’s degree in Engineering is required. A Masters or PhD is an advantage.
2. Demonstrated validation experience/ exposure
3. 1-3 years experience in Medical Devices or regulated industry and exhibiting evidence of GDP and technical writing
If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or firstname.lastname@example.org for further information.