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Contact Info
Joan O'Malley
Life Science

0871897333
[email protected]
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Details

Senior Design Assurance Eng


Reference:JOM/AEUS-371203 Location: Galway City
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Design Assurance


Senior Design Assurance Engineer


Location: Galway, Ireland

  • Responsible for ensuring Design control and Risk Management activities, wherever they are performed comply with the requirements of Design Control and Risk Management processes.
  • Provide Quality support/guidance to R&D projects leads/team members.
  • Provide direction and support to Design Assurance engineers and Quality Engineers.
  • Co-ordinate the Design Assurance Engineer resources to support business objectives.
  • Resolve project issues by working with team members, suppliers, and others as appropriate.
  • Apply systematic problem-solving methodologies in identifying, prioritizing, presenting, and resolving quality issues.
  • Manage and maintain the records related to design control projects.
  • Generation of risk management file documents; Risk Management Plan, dFMECA, pFMECA and associated reports.
  • Provide recommendations into development of protocols / reports supporting the Design control process.
  • Provide recommendations and review to protocols and reports for sterilization, biocompatibility and packaging validations.
  • 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.
  • Review and approval of production records and sterilization records of product manufactured during the design control process to facilitate timely approval of Design protocols and reports.
  • Support the translation of the design requirements into manufacturing requirements.
  • Leads and/or facilitates compliance and improvement activities associated with the quality system (e.g. CAPA). 21 CFR 820, ISO13485
  • Act as an audit escort and/ or support coordination of backroom activity during inspections as required.
  • Perform internal/Supplier audits as scheduled and maintain internal audit records.
  • A minimum of a Bachelor’s Degree is required, preferably in Engineering or related technical field.

  • Minimum 3 years’ experience in the medical device industry and/or IVD/pharmaceutical, with at least three years in a position with direct responsibility for QMS processes/sub-processes.




Any applicant must be eligible to work in Ireland. Existing work permit or EU passport required.


Contact Joan O’Malley at 087-1897333 for more details.