Connecting...

Quality Systems Analyst

Job description

My client a world leader in healthcare urgently require a Quality Engineer (QSE).

Whay you'll need :

  • Responsible for the  continuous review of the CAPA & Internal & Compliance programs 
  • Drive and implement process improvements to ensure predictable processes across all lines.
  • Ensure all process variables and their interactions are adequately defined.
  • Ensure all failure modes in process are identified & addressed. (e.g. Use of DOE studies, FMEA's).
  • Exposure to internal auditing & familiar with all reg. requirements (e.g., FDA, ISO and MDD/MDR ).
  • Provide functional expertise to other support functions on quality related issues
  • Validation: Define process, product and test method validation requirements,
  • Compilation of required Regulatory documentation.
  • Educational Requirements:
  • - Minimum qualification: BSC/BEng degree.
  • Familiar with Quality Systems: ISO 9001, ISO 14001, OHSAS 18001 &  BRC Packaging 
  • - Minimum of 2 years experience in a QA role.
  • For more information please call Colin by E-Mail codonnell@sigmar.ie

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.