Location : Mayo
The purpose of the position is to provide Quality Engineering services for the site. Develop and implement Master Validation Plans, Risk Assessments and lead QE activities in the Value Stream
- Develop Master Validation Plans
- Develop and complete DV/IQ/OQ/PQ protocols
- Contribute to the development of FAT/SAT protocols
- Execute Validation Protocols, root cause deviations and generate validation reports
- Develop product specifications / drawings / quality plans in conjunction with NPD personnel
- Provide QE support for New Product Development (NPD) projects
- Process Risk Management / FMEA
- Complete internal audits per the audit schedule
- Co-ordinate and implement process capability analysis on catheter processes
- Complete CAPA investigations
- Lead Production System (HPS) audits for the department
- Degree in Engineering/Science Discipline and Quality Engineering Qualification
- Experience in statistical analysis / SPC / validation of automated equipment
- 5 years experience in Medical Device Industry utilizing automated equipment
- Masters degree in Engineering/Science Discipline an advantage
For further information on this role in Mayo please contact Katie Kilbane on 0861283368 or email@example.com
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