Quality Engineer (Validation Project)

The purpose of the position is to provide Quality Engineering and Process Validation services for Continence products in the CCBM Plant.

RESPONSIBILTIES:

  • Complete Process and Equipment Validation including DV, IQ, OQ, PQ protocol development, implementation and report completion.
  • Develop product specifications / drawings / quality plans in conjunction with NPD and project team.
  • Conduct Risk Management / FMEA / Statistical analysis.
  • Complete ISO 13485 / FDA and QSR internal audits per annual schedule.
  • Implement process control and ensure process capability is maintained and identify opportunities for process improvement.
  • Conduct CAPA analysis to determine root cause and complete problem resolution.
  • Personnel training.

QUALIFICATIONS:

  • Degree in Engineering/Science Discipline
  • Quality Engineering Qualification
  • Experience in statistical analysis / process validation
  • 2/3 years experience in Medical Device Industry
  • Ability to participate in cross functional teams

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.