Quality Engineer – Permanent

Our client is a global leader in eye care, manufacturing and developing innovative eye devices worldwide, reaching 90% of the globe. Due to multiple ongoing and new projects, an opportunity has arisen for a Quality Engineer to join their Cork site on a permanent basis.

The Position

As the new Quality Engineer, you will lead a cross-functional team to identify and implement process improvements and provide Quality Engineering support to manufacturing process and quality systems. You will also be respoinsible for:

  • The review of change controls for quality system compliance including validation impact.
  • The review and/or development and execution facility, process, equipment and software validations including risk management summaries.
  • Supporting Engineering and Manufacturing teams and leading investigations as required.
  • Supporting and managing projects on time, within budget and to meet business requirements.
  • Using knowledge of statistics to assist with process improvements, validation developments and process/product investigations.

The Person

The ideal Quality Engineer will be degree qualified in a technical discipline and have 5+ years’ quality engineering/technical experience along with validation experience (equipment, process and software) in either medical device or pharma. You will also demonstrate:

  • Strong knowledge of life cycle, CSV/GAMP requirements.
  • Knowledge of FDA, medical device, cGMP requirements.
  • Working knowledge of statistical analysis.

To learn more apply on line or call Chris Dennehy on +353 21 4511195.

Salary: €55000 - €55000 Location: Cork city