Quality Engineer (CSP)

Galway
​Contract
Job Title/ Position:              
Quality Engineer (centralised packaging and sterilisation)
 
Required Qualifications/Experience/Skills:
Degree in Quality / Technical with emphasis on Medical Device Industry
Minimum 5yrs previous experience in Quality/Validation in Medical Device/Pharma Environment, with knowledge of sterilisation processes – EO and Irradiation.
 
 
Duties:
This involves but is not limited to: 
  • SME for sterilisation processes for new product introductions (NPI) and maintenance of existing validated sterilisation cycles within the site(s).
  • Participation in the new product introductions programme to ensure that they are effectively introduced in accordance with requirements.
  • Participate and assist with other validations that can impact on the sterilisation processes, such as packaging validations for example.
  • Carry out other NPI activities in relation to QA / QE activities as required to support the NPI / R&D processes.
  • Participation in the Customer Complaint investigation process and participation in routine failure investigation & process trouble-shooting for all issues reported in cleanrooms.
  • Participation in the Site Corrective Action Programme
  • Participation in the Internal Quality Audit Programme