Our client, a medical device organisation based in Connacht are seeking an experienced Quality Engineer to work within projects and support QA activities. This role will report directly to the Validation Supervisor.
Duties and responsibilities of the Quality Engineer will include:
- Complete Process and Equipment Validation including DV, FAT, IQ, OQ, PQ protocol development, implementation and report completion per timelines
- Support compliance activities and quality improvements as required
- Completion of statistical analysis in compliance with Quality System requirements
- Leading and executing PFMEAs.
- Assist in CAPA investigation.
You will have skills and experience in the following:
- Degree in Engineering/Science Discipline and Quality Engineering Qualification or equivalent.
- Minimum 5 years' relevant experience in the medical device industry or equivalent regulated industry.
- Knowledge of statistical analysis, ISO 13485 and FDA 21 CFR Regulations.
For more information on this opportunity, talk to Laura Gallagher in confidence, email or call her direct line 00 353 91782113.