Senior Quality Engineer (Validations)

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

QUALIFICATIONS:  

  • 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.