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Cleanroom Quality Engineer

Job description

Cleanroom Quality Engineer

Our client, who specializes in minimally invasive devices is looking for a Cleanroom Quality Engineer to join their team on a full time, permanent basis in Waterford. This is a great opportunity for a passionate individual to progress within their career.

Job responsibilities:

  • Responsible for the cleanroom facility management (qualification/ maintenance/ extensions) including HVAC and supportive utilities within a GMP compliant Quality Management system
  • Support NPI team in the execution of Performance Qualification for the clean room processes
  • Responsible for planning and execution of Periodic Review and Revalidation activities for clean utilities, systems and equipment
  • Maintains and implements environmental controls
  • Support deviation investigations throughout the facility
  • Participate in risk assessments, inspections, audits, incident investigations
  • SME for appropriate statistical techniques to monitor process performance

Job requirements:

  • Honours (level 8) Degree in Mechanical/ Manufacturing / Production engineering or similar
  • Knowledge of Reg requirements
  • Knowledge of cleanroom environmental monitoring
  • Minimum 5 years’ experience in a production environment
  • Minimum 5 years’ experience in quality department
  • Minimum 5 years ‘experience Customer Complaints Management experience
  • GMP experience essential
  • ISO 9001-13485 CFR 820 knowledge essential
  • Exposure to SPC and validations

If you would like to discuss this role, reach out to Louise Whitty on 021 2359140 / lwhitty@sigmar.ie

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