Quality Assurance Engineer – Galway

Interested in working for a leading medical device manufacturer? You will be responsible validating all design activities within the organisation.

Responsibilities:

  • Performs technical reviews of design documentation and labeling and attends reviews.
  • Coordinates completion of design risk management documentation and acts as reviewer for all design activities.
  • Support new test development and appropriate validation.
  • Quality approver on all relevant records, tests, validations, reports, project file entries etc.
  • Implement software validation on device and supporting software based systems.
  • QA lead for product design transfer/validation strategy development.
  • Supports external audits including notified body and FDA audits.
  • Promotes the awareness of regulatory and customer requirements.

Requirements:

  • BSc. in Engineering, Technology, or Science
  • 2-4 years’ experience working in a regulated medical device company
  • Experience in software validation advanaegous.
  • Excellent planning and coordination skills.
  • Knowledge of mechanical ventilation advantageous
    Formal training in medical device risk management advantageous.
  • Excellent data analysis skills.
  • Excellent understanding of ISO 13485 and FDA QS regulations.
  • Understanding of R&D stage gate/waterfall process.
  • Ability to apply relevant medical device standards.
  • Some travel may be required.
  • Must be authorised to work in Ireland.

Please contact Mary-Ann Keena to learn more

maryann@emtechrecruitment.ie

+353 (0) 83 0220666

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