Job ID: JOB-11322
Senior Quality Engineer

A leading medical device company in Mayo is looking to hire a Senior Quality Engineer on a permanent basis.

Summary

The primary purpose of the Ostomy Senior QE role is to support Ostomy 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 timelines
• Support Ostomy Compliance activities and support quality improvement projects
• Completion of statistical analysis in compliance with Quality System requirements
• Leading and executing PFMEAs.
• Mentor and support Ostomy QEs through projects and ensure completion of projects per timelines
• Lead Ostomy projects and ensure completion of projects per timelines • Work with the Validation Supervisor on team development activities

Requirements

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

For further information on Senior Quality Engineer role in Galway please contact Clara Burke on 086 8168273 / science@hero.ie

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Clara Burke

JOB-11322