Quality Specialist

Competitive
Permanent
Dublin
13 May 2019
BBBH730153

Have you 1 years post graduate experience in Quality Assurance?

Quality Specialist- Medical Device- Dublin

Have you 1 years post graduate experience in Quality Assurance? Excellent opportunity to join a growing leader in personal health testing.

Job Purpose:

The client are looking for a Quality Specialist to enhance our growing team. As a Quality Specialist, you'll provide support to the Operations, Engineering and Quality Management functions. You will lead the development of validations and change management initiatives in-line with Medical Device Manufacturing Regulations for a class 1 device and business requirements with the main market focus being the US.

Key Responsibilities:

  • Develop, maintain and continuously improve the Quality Management System.
  • Ensure all regulatory requirements are met and understood by all team members.
  • Report writing and data analysis.
  • Document control, Training, Root cause analysis of non-conformance and CAPA's.
  • Equipment control including validation and preventive maintenance.
  • Communication with suppliers regarding all quality related matters.
  • Reviewing and investigating customer complaints and implementing appropriate actions when required.
  • Perform risk management activities.
  • Drives compliance cross-functionally in alignment with the regional objective for collaboration and multi-site ISO certification.

Education and Experience:

  • A Bachelor's degree in scientific discipline or a related field
  • Experience in a similar role in the medical device industry is desirable
  • Experience of validating processes to medical device regulatory requirements
  • Project management experience
  • Knowledge of analytical and statistical techniques, including SPC and inspection and test methodologies
  • The ability to develop and write protocols, validation reports and engineering reports
  • Competent working knowledge of recognized Quality Management Systems
  • Awareness of relevant laws and regulations (e.g. MDD/ FDA/ PAL)
  • Broad knowledge of engineering and technical applications applied in the development of medical devices useful.

Morgan McKinley is acting as an Employment Agency in relation to this vacancy.

Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.

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Fiona Durkin's picture
Senior Consultant | Quality & Validation | Dublin & South East
01 6324650 | fdurkin@morganmckinley.ie