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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.

Key Responsibilities

• 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/
  Customer requirement.
• 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
  maintain quality.
• 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.

Key Requirements

• 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 talent@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

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Mark Wilson

JOB-12037

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