Collins McNicholas

QUALITY ENGINEER

The primary purpose of the QE role is to support projects and support any other QA activities on site as required. The primary customers include Engineering, Manufacturing, Supply Chain Management and Product Development.

RESPONSIBILITIES:

Complete Process and Equipment Validation including DV, FAT, IQ, OQ, PQ protocol development, implementation and report completion per timeline
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.

QUALIFICATIONS:

Degree in Engineering/Science Discipline and Quality Engineering Qualification or equivalent
Knowledge of statistical analysis, ISO 13485 and FDA 21 CFR Regulations
5-8 years Relevant experience in the medical device industry or equivalent regulated industry

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For a confidential discussion and more information on the role, please contact Davin Ferguson on 0719140251 or email davin.ferguson@collinsmcnicholas.ie

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