Overview

Senior Quality Engineer required for our client in Mayo

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 Hollister Production System (HPS) audits for the department
  • Supervision of Quality Engineers and Associate Quality Engineers during project activities

QUALIFICATIONS:

(Bona-fide minimal qualifications for the position)

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

For more information, Contact Mairéad at Arcon Recruitment

Mairead Kelly, marketing and recruitment consultant at Arcon Recruitment Services. PHOTO: ALISON LAREDO

Mairéad Kelly

Recruitment Consultant

Mairéad initially joined our team as Marketing and Recruitment Co-ordinator. She quickly progressed to Recruitment Consultant and currently manages our busy Technical division. Mairéad is a proud Castlebar woman and holds a B.B.S from ATU Sligo. Mairéad recruits for positions in all areas of Technical/ Engineering and I.T.  She has built excellent relationships with companies large and small and has proved herself invaluable in solving their recruitment issues.

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