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Quality Systems Engineer

Job description

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

Are you passionate about contributing to life saving patients.?

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.
  • - Minimum of 2/3 years experience in a QA role.
  • For more information please call Colin by E-Mail codonnell@sigmar.ie

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