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Quality Systems Engineer

  • Sector: Engineering
  • Contact Email: michelle.mcinerney@collinsmcnicholas.ie
  • Job Ref: 18862

Our client based here in Galway are looking for a Quality Systems Engineer for an exciting new project. This exciting role offers a Hybrid working Model.


Job Purpose:

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. Working in the QA Dept, this person will have day-to-day responsibility for the running of QA-based systems; document control, monitoring, and development of all Quality System components running of NCR and CAPA systems, oversight of Labelling control system.


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 practices.
  • 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 the 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 the occurrence of any non-conformity relating to product, process, or system.
  • Undertake special projects as required.
  • Contribute to continuous improvement activities.
  • Take part in third-party audits as required.

Requirements:

  • Demonstrable Knowledge of medical device quality systems and ISO13485.
  • Excellent Computer Skills (word, excel, PowerPoint, and Access).
  • Excellent communication (both verbal and written) & interpersonal skills.
  • An analytical approach to problem-solving.
  • A self-starter that applies their own initiative in most situations.
  • A team player, who works well in a smart team environment, must be able to work effectively with peers in other departments.
  • A good communicator who can easily convey his/her ideas and requirements across all levels in the organization.
  • CAPA, Auditing, and Risk Management experience.
  • Good organizational skills and ability to track and drive activities to closure.

Qualification and Education requirements:

  • Requires a Level 8 or higher degree in an engineering or science discipline.
  • Previous experience within the medical device industry in a Quality Engineer role is essential.
  • Minimum of 4 years of quality experience in a quality function with proven quality assurance experience within Medical Devices.
  • Recent experience with FDA GMP requirements is highly desirable.

For a confidential discussion and more information about the role please contact Michelle Mc Inerney

at michelle.mcinerney@collinsmcnicholas.ie

091 706 717