Quality Systems Engineer

HERO

Job Detail

Location Galway Mervue
Salary Negotiable
Posted
Role Type Permanent
Contact Mark Wilson
email talent@hero.ie

Quality Systems Engineer

Apply Now

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/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given.  You have supplied us with your personal data in the process of applying for a position.  Our client company may have personnel outside of the EEA who will review you data.  We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

 

Mark Wilson

JOB-12037

Apply Now

Quality Systems Engineer

Mark Wilson

Role Type Permanent
Contact Mark Wilson
email talent@hero.ie
mobile +353 86 044 94 73
linkedIn profile click here

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