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Quality Systems Manager

  • Sector: Engineering
  • Contact Email: michelle.mcinerney@collinsmcnicholas.ie
  • Job Ref: 21556

Our client a global medical device company who are setting up operations here in Galway are looking to hire a Quality Systems Manager.


The Role:

As the Quality Systems Manager you will take the lead in ensuring that the quality system is maintained and implemented in a compliant manner and areas of improvement are identified and implemented as required. This will involve coordinating and working with all functions in a collaborative manner where quality system compliance is dependent.

 

Responsibilities:

  • Lead and develop the Quality System function to deliver a best in practice Quality System driving performance and compliance.
  • Take responsibility for compliance with Quality System including, Management Review Coordinator, CAPA, Document Control, Training, Product Quality Review,, Internal Audit, Complaints, as well as Continuous Improvement and Simplification Initiatives.
  • Ensure that products manufactured meet the requirements of end-users, Regulatory Authorities and the company.
  • Develop and maintain performance measurements of the quality system and report on this at management review meetings and during quality performance meetings
  • You will liaise with Regulatory bodies to ensure Quality Systems compliance by all departments and personnel.
  • Manage ongoing Quality Systems Compliance issues, and present technical data to stakeholders to ensure prompt decisions on related issues.

Requirements:

  • A degree in Engineering, Technology, or Science.
  • 10+ years’ experience working in a regulated medical device company
  • Demonstrated audit/inspection experience.
  • Excellent verbal and written communication skills
  • In-depth knowledge of QMS Requirements and Regulations
  • Ability to work within a team environment to achieve agreed company goals.
  • Ability to communicate quality / regulatory concepts effectively.
  • Excellent understanding of EN ISO 13485 and FDA regulations.
  • Formal Audit Training.
  • Some travel may be required with the role.

For more information or a confidential discussion about this role please contact Michelle McInerney

michelle.mcinerney@collinsmcnicholas.ie

091 706 717