Medical Devices JobsSenior Quality Engineer (Validations)

  • SJ51087
  • Permanent
  • Mayo, Sligo

Collins McNicholas

Senior Quality Engineer (Validations)

Reporting to Validation Project Manager, the purpose of this position is to provide Quality Engineering services to the Plant Value Stream and contribute to the growth and profitability of the site.  As Senior Quality Engineer you will develop and implement Master Validation Plans, Risk Assessments and lead QE activities in the Value Stream.

Main Responsibilities:

  • Develop Master Validation Plans
  • Develop and complete DV/IQ/OQ/PQ protocols
  • Contribute to the development of FAT/SAT protocols
  • Execute Validation Protocols, root cause deviations and generate validation reports
  • Develop product specifications / drawings / quality plans in conjunction with NPD personnel
  • Provide QE support for New Product Development (NPD) projects
  • Process Risk Management / FMEA
  • Complete internal audits per the audit schedule
  • Co-ordinate and implement process capability analysis on catheter processes
  • Complete CAPA investigations
  • Lead Production System audits for the department
  • Supervision of Quality Engineers and Associate Quality Engineers during project activities

 

Requirements:

  • Degree in Engineering/Science Discipline and Quality Engineering Qualification
  • Experience in statistical analysis / SPC / validation of automated equipment
  • 8 years’ experience in Medical Device Industry utilizing automated equipment
  • Experience of people management
  • Master’s degree in Engineering/Science Discipline an advantage

 

****************************************************************************************

First Name

Surname

Your Email (required)

Your mobile (required)

Comment / Cover Letter

Upload CV

In order to provide you with our services, we need to process certain personal information about you. We will only use your personal information to deliver the job-seeking or related services you have requested.

We seek your consent to store your data and provide you with the best possible service. If you have any questions regarding our legal obligations to you or your rights under the GDPR please refer to our privacy statement which clearly outlines all of your rights.