Quality/Validation Engineer

Website Ref:TPM04650

Summary:
Our client, a global healthcare company based in Waterford is looking for a Validation Engineer to represent the quality function of technical support, in conjunction with other internal support groups, regarding issues affecting manufacturing on global customer accounts. The successful candidate will serve as liaison between our client’s Circuit and suppliers or customers on global quality related issues.

Responsibilities:

  • Facilities, New Assembly lines URS writing.
  • Master Validation Plans writing.
  • Moulding/Assembly Validation Protocol and Reports Writing, Execution and Review.
  • Equipment Qualification Reports writing and review.
  • Conduction of pFMEA for Assembly and Moulding Processes.
  • Support for NPI Quality – Deviations, non conformances, root cause investigation/analysis, CAPA writing and reviewing.
  • Metrology/Data Processing (Statistics) and Reporting.
  • Presentation of Validation documentation to Clients, Face to Face meetings with Clients, addressing of Client queries and questions.
  • Represent Validation in Audit Clients and Regulatory Inspections.
  • Provide training to Operations team on Quality/Validation Areas.
  • Cleanroom and Utilities validation protocols and reports (Execution and Review).

Qualifications & Experience:

  • Bachelor’s degree required.
  • 5 years related experience; or equivalent combination of education and experience.

To apply for this job email your details to orla.daly@tandempm.ie.