Overview
Our client is seeking a QA Engineer
RESPONSIBILITIES:
- 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
QUALIFICATIONS:
(Bona-fide minimal qualifications for the position)
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
Master’s degree in Engineering/Science Discipline an advantage
For more information, Contact Mairéad at Arcon Recruitment