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Design Quality Engineer | Galway

  • Sector: Engineering
  • Contact Email:
  • Job Ref: 20788

Our client based here in Galway are looking for a Design Quality Engineer on an initial 12-month contract.

The Role:

 As the Design Quality Engineer you will provide QA technical and compliance expertise as part of teams tasked with establishing customer needs, developing new products and/or modifying existing designs. You will be responsible for ensuring s compliance to applicable regulations and completing quality activities such as risk assessments, device testing, QMS/data audits, procedure development, documentation review and changes to controlled documents. You will also provide design control, risk management, and compliance support for product design and manufacturing, corrective and preventive actions, product/process improvements, and complaint investigations.


  • Responsible for ensuring Design control and Risk Management activities, wherever they are performed comply with the requirements of the Design Control and Risk Management processes.
  • Provides Quality support/guidance to R&D and Lifecycle Management projects leads/team members.
  • Resolves project issues by working with team members, suppliers, and others as appropriate.
  • Manages and maintains the records related to design control applicable to product development and design/manufacturing change projects.
  • Provides input into the generation of risk management file documents; Risk Management Plan, dFMECA, pFMECA and associated reports.
  • Provides input into the development of protocols/reports supporting the Design control process.
  • Provides input and review to protocols and reports for sterilization, biocompatibility and packaging validations.   
  •  Coordinates the timely review and approval of all details in R&D batch sterilization records as meeting the requirements of the cycle validated and appropriate for the product.
  • Coordinates the review and approval of production records and sterilization records of products manufactured during the design control process to facilitate timely approval of Design reports.
  • Supports the translation of the design requirements into manufacturing requirements.
  •  Ongoing monitoring of data from Quality Management systems and provision of immediate feedback to quality management on deviations or issues of concern.
  • Administration and management of systems for CAPA, non-conformances, and for supplier corrective actions.
  • Leads and/or facilitates compliance and improvement activities associated with the Quality System (e.g. CAPA)
  • Supports internal/Supplier audits as applicable.
  • Supports regulatory activities as requested by management.


  • Minimum education of degree in a technical field is preferred.
  • Minimum 3 years experience in the medical device industry and/or IVD/pharmaceutical preferred.
  • Knowledge of the application of the principles, concepts, and practices of design control, sterilization, and Quality Assurance processes is beneficial.
  • Knowledge of basic QMS requirements and processes.
  • Knowledge of 21 CFR 820, ISO13485 with familiarity with other foreign medical device quality system requirements.

For more information or a confidential discussion about this role please contact Michelle McInerney


091 706 717