Medical Devices JobsSenior Quality Engineer (Validation)

  • SJ51712
  • 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:

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

Requirements:

  1. Degree in Engineering/Science Discipline and Quality Engineering Qualification
  2. Experience in statistical analysis / SPC / validation of automated equipment
  3. 8 years’ experience in Medical Device Industry utilizing automated equipment
  4. Experience of people management
  5. Master’s degree in Engineering/Science Discipline an advantage

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  1.  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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