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
- 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 Bimi Felix on 086 8395533 / email@example.com
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