Quality Systems Engineer – Galway

This is key role within a leading medical device company. You will be responsible for conducting internal audits as well as facilitating external audits.

Responsibilities:

  • Coordinate the internal audit system and audit team to ensure completion of all.
  • Conduct Quality Audits as necessary.
  • Lead preparation and coordination activities for external audits.
  • Co-ordinate the document control function in conjunction with the appropriate resources.
  • Identify regulatory compliance issues.
  • Coordinate the complaints system.
  • Coordinate quality system review and reporting.
  • Promotes the awareness of regulatory and customer requirements.
  • Supports quality training on site.
  • Manage the environmental monitoring process and system for the organisation.

Requirements:

  • BSc. in Engineering, Technology, or Science.
  • 3-5 years’ experience working in a regulated medical device.
  • Excellent planning and coordination skills.
  • Ability to communicate quality / regulatory concepts effectively.
  • Excellent understanding of EN ISO 13485:2016, MDSAP ad FDA regulations.
  • Formal Audit Training
  • Proficient in MS office package.
  • Some travel may be required with the role.
  • Must be authorised to work in Ireland.

Please contact Mary-Ann Keena to learn more

maryann@emtechrecruitment.ie

+353 (0) 83 0220666

Refer a Friend