Overview

Our client is seeking a QA Engineer

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 (HPS) audits for the department

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

5 years’ experience in Medical Device Industry utilizing automated equipment

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 fills the very busy position of Recruitment Administrator in Arcon. This position is multi-faceted and involves providing support to the Recruitment team. Mairead’s day is never typical, and she has a great ability to prioritise tasks in an ever-changing and pressurised environment. Mairéad also manages our extensive database and regularly “catches up” with our registered candidates to make sure the information we have on file is always up to date and correct.

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