Our client, a medical device organisation based in Connacht are seeking an experienced Senior Quality Engineer to work within projects and support QA activities. This role will report directly to the Validation Supervisor.
Duties and responsibilities of the Senior Quality Engineer will include:
- Complete Process and Equipment Validation including DV, FAT, IQ, OQ, PQ protocol development, implementation, and report completion.
- Support compliance activities and quality improvements.
- Completion of statistical analysis in compliance with Quality System requirements.
- Leading and executing PFMEAs.
- Mentor and support QEs through projects and ensure completion of projects.
- Lead projects and ensure completion of projects.
You will have skills and experience in the following:
- Degree in Engineering/Science Discipline and Quality Engineering Qualification or equivalent.
- 5-8 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.