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Vacancy Details


Quality Systems Engineer - Galway - 103220

Contract Type: Permanent
Location: Galway
Date: 22/05/2019
Job Reference: 103220
Contact Name: Anna Carty
Contact Email:

Job Description

Quality Systems Engineer - Galway - 103220
Quality Systems Engineer

Our client, a medical device company in Galway is currently looking to recruit a Quality Systems Engineer for their site.

The Quality System Engineer is a member of the Quality Systems department. S/he is responsible for ensuring that quality system functions that she s/he is responsible for are maintained in compliance with documented procedures. S/he supports the Quality System to ensure on-going compliance and continuous improvement. This function will liaise with various departments to ensure the quality system is in compliance

  • Actively stays current with external and internal quality system standards and requirements.
  • Providing Quality Systems support for the Galway site.
  • Support QMS integration activity across the Galway site.
  • Responsible for coordinating and managing all external audits.
  • Responsible for managing the site internal audit process.
  • Responsible for managing the site internal CAPA process.
  • Approvals as defined on Oracle.
  • Identifies deficiencies in quality systems and defines systematic corrective actions.
  • Develops effective quality metrics and communicates the results to key stakeholders using reports, presentations, and dashboards.
  • Ensure compliance and drive improvements in QS processes.
  • Assists in the preparation and maintenance of records associated with the management review process.
  • Participates in Quality Systems projects under the direction of the Quality Director as well as other duties as assigned.
  • Monthly Manufacturing Training Report (provided to HR, accounting for all training data analysis
Key Requirements:
  • Level 8 Degree in Quality Assurance or Degree in Science/Engineering with an additional qualification/experience in Quality Assurance.
  • A minimum of 2 years’ experience as a Quality Engineer within the Medical Devices or Pharmaceutical industry.
  • Strong working knowledge and proven track record in the all aspects of ISO13485 and FDA QSR requirements.
  • Regulatory experience / knowledge.
  • Excellent communication and inter-personal skills.
  • Proven ability to influence.
  • Excellent attention to detail and report writing skills.
  • Highly organized with strong ability to prioritize tasks and work on own initiative.
  • Trained Auditor ideally lead auditor training and/or experience

For further information on this Quality Systems Engineer role in Galway please contact Anna Carty on 086 816 8298 /

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