Senior Quality Engineer

SUMMARY:

  • The purpose of the position is to provide Quality Engineering services
  • Plant Value Stream (Continence Care) and so contribute to the growth and profitability of the company.
  • Develop and implement Master Validation Plans, Risk Assessments and lead QE activities in the Value Stream.

RESPONSIBILTIES:

  • 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 please either call me on 087 922 1136 or email me at sean@arconrecruitment.com

Your Recruitment Consultant is Sean Winstanley

Sean Winstanley
Sean joined Arcon Recruitment in early 2018 as our Specialist Technical Recruiter. Originally from the UK, now settled in Ballaghadrereen, Sean brings a wealth of recruitment experience in the IT / Technical arena. Sean has developed excellent skills account managing international, high profile clients solving their recruitment dilemmas.