Quality Engineer – Medical Devices

A Medical Device multinational is seeking an experienced Quality Engineer with at least three years experience coming from a Medical Device or Pharmaceutical background to join their team. You will be responsible for the continuous improvement of the organisations Quality Management System.

Responsibilities:

  • Development and continuous improvement of the Quality Management system.
  • Quality planning and new product introduction from a quality perspective.
  • Establish and maintain risk management principles and methods.
  • Maintain relevant documentation to comply with quality standards.
  • Develop strong links with customer organization’s.
  • Investigation of root cause and implementation of effective corrective actions.
  • Overall responsibility for production GMP standards and compliance.
  • Establishing inspection standards, sampling plans and test methods.
  • Preparing and updating operations procedures and associated documentation.
  • Supporting customer audits and surveillance audits.
  • Conduct attribute test method validations.
  • Support the validation activity for process changes and conduct the quality review.

Requirements:

  • BSc. in Quality or Degree in Science / Engineering.
  • 3+ years experience as a Quality Engineer.
  • 3+ years experience in a medical device-manufacturing.
  • Green belt problem-solving qualification preferred.
  • Strong knowledge of FDA/ISO/MDD Quality systems for Medical device companies.
  • New product introduction and manufacturing process transfer advantageous.
  • Quality experience in component and device manufacturing desirable.
  • 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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