Quality Systems Engineer
Job ID: JOB-12037
Quality Systems Engineer
Our Client, a global leader in medical device manufacturing are actively looking for a Quality Systems Engineer to join their team in Galway. Reporting to the Quality Manager, the Quality System Engineer is a team member of the Quality team with responsibility for establishing, implementing and maintaining the Quality System onsite. This role includes people management and the successful individual may have up to a team of 4 reporting directly to them.
- Identify and implement effective process control systems to support the continuous
improvement of the quality systems as a whole.
- Oversee and be actively involved in all QA office systems and functions.
- Direct involvement in routine Document Control, NCR and TA activities.
- Develop and implement quality metrics and reporting systems.
- Support and deliver continuous improvements and to employ problem solving tools
including root cause analysis and CAPA identification.
- Preparation of Quality reports for Quality meetings and management reviews.
- Oversee all in house label control systems.
- Acts as an effective team member in supporting quality disciplines, decisions and
- Facilitate the New Product Introduction processes along with other Engineering
functions to ensure NPI procedures are efficient and effective in satisfying the QMS/
- Apply sound, systematic problem solving methodologies in identifying, prioritizing,
communicating and resolving quality issues.
- Suggest changes in procedures and standards to facilitate work efficiency and
- Ensure regulatory compliance to GMP for all medical device regulatory agencies.
- Participates in new product/technology development and supports the QA activities
as part of an overall project team.
- Perform an active role in continual improvement of the Quality System.
- Conduct internal quality audits to ISO13485 and GMP requirements.
- Report on Key Performance Indicators (KPIs) in order to adhere to process and
prevent occurrence of any non-conformity relating to product, process or system.
- Demonstrable Knowledge of medical device quality systems and ISO13485.
- Requires a Level 8 or higher degree in an engineering or science discipline.
- Minimum of 4 years of quality experience in a quality function with proven quality
assurance experience within Medical Devices.
For further information on this role please contact Mark Wilson on 0860449473 or email email@example.com
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