Production

Quality Engineer

  • Full Time
  • Remote
  • Cork
  • 41822468

Job Summary: 

Plans and conducts activities concerned with the quality control and quality assurance of products manufactured in cleanrooms under ISO 9001:2015

                                                                                                                                

*Essential Job Duties:

  • Work as part of a value stream to ensure appropriate quality oversight and support to operations
  • Drive continuous improvement and embed a culture of quality to ensure ongoing compliance with ISO9001:2015 standards
  • Troubleshoot complex problems as part of a cross functional value stream
  • Ensure the QMS is in place, in use and aligned to current regulatory expectations
  • Design and implement test plans and audits for products to ensure product quality targets are met
  • Establish, define, implement, maintain, and report on quality assurance key performance measures and standards
  • Investigate non-conformances and consumer complaints, perform root cause analysis, implement corrective actions, and monitor progress and improvements
  • Create and maintain quality systems documentation, such as quality manuals, procedures, and work instructions
  • Perform quality assurance and qualification audits on vendors/suppliers
  • Participate in and host customer audits of the facility
  • Devises sampling procedures, design and develop forms and instructions for recording, evaluating, and reporting quality data
  • Write technical reports
  • Coach and support others in relation to quality best practices as required

 

Qualifications:

  • Bachelor of degree in Engineering, Science or equivalent
  • 4+ years of experience working in a regulated environment (ISO accredited, Pharmaceutical, medical devices etc.)
  • Familiarity with cleanroom manufacturing
  • Working knowledge of Microsoft Office applications
  • Experience in general quality systems (internal and external audits, CAPA management, customer complaints handling, non-conformance management etc.)
  • Ability to articulate complex problems in a clear concise manner through effective communications and technical report writing skills
  • Strong analytical problem solving skills
  • Demonstrated ability to work collaboratively as part of a cross functional team

Interested candidate shsould submit an up to date CV to be considered for the role or contact Sean on 0214297900 or Sean.Barron@peglobal.net

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