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Senior Quality Engineer- Design Assurance

  • Location:

    Ireland

  • Contact email:

    mtully@sigmar.ie

  • Sector:

    Engineering

  • Contact phone:

    014744600

  • Job type:

    Contract

  • Job ref:

    MTuSQEDA2020

  • Salary:

    Negotiable

  • Published:

    27 days ago

  • Contact email:

    mtully@sigmar.ie

Job description

Job Responsibilities

  • Responsible for product quality, DHF documentation, Compliance, Patient Safety and customer satisfaction.
  • Design Assurance QE on project core teams.
  • Lead risk management activities within the project.
  • Review and approve test protocol, reports and approve related execution deviations.
  • Assist/Conduct failure investigations and problem-solving.
  • Ensure process validation activities are completed appropriately.
  • Conduct quality functional reviews and DHF compliance reviews.
  • Ensure compliance across projects for design control, risk management and change control processes. 

Job Requirements

  • Minimum level 8 degree in related discipline.
  • Proven expertise in design assurance including design controls and risk management (ISO 14971).
  • Experience reviewing and approving test protocols and SPC.
  • Experience working with Design History files (ISO 13485).
  • Working knowledge of the medical device sector.
  • Additional experience with Software Quality (ISO 62304).
  • Capital equipment validation and reliability testing an advantage.

For a confidential discussion on this or any other current job opportunity please contact Meggan on 021 235 9144 / mtully@sigmar.ie

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.