Quality System Engineer – Galway

An excellent opportunity to join a medical device team in maintaining and collaborating with the entire team to ensure compliance is being achieved.

Key Responsibilities:

  • Coordinate the internal audit system and audit team.
  • Conduct quality audits as necessary.
  • Coordinate external audits and ensure audits are conducted efficiently.
  • Coordinate the document control function.
  • Identify any adverse trends or regulatory compliance issues.
  • Coordinate the complaints system to ensure that all complaints are completed.
  • Coordinate quality system review activities and reporting.
  • Promote the awareness of regulatory and customer requirements.
  • Supports quality training on site.
  • Methodical review approach and be capable of initiating and leading change and continuous improvement.
  • Manage the environmental monitoring process and system for the manufacturing area.

 

Requirements: 

  • BSc. Degree in Engineering, Technology, or Science
  • 3-5 years’ experience working in a regulated environment – medical device or pharmaceuticals
  • Understanding of EN ISO 13485:2016, MDSAP ad FDA regulations
  • Formal Audit Training
  • Excellent planning and coordination skills
  • Excellent verbal and written communication skills
  • Excellent attention to detail skills
  • Ability to work within a team environment to achieve agreed company goals
  • Ability to communicate quality / regulatory concepts
  • Some travel may be required with the role
  • Must be authorised to work in Ireland

Please contact Emer Moore to discuss in confidence
00353578638188       
emoore@emtechrecruitment.ie

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