Quality Assurance Engineer – Leitrim

A medical device multinational is seeking an experienced Quality Assurance Engineer to join their team. You will be responsible for the maintainence of the organisations quality management system.

Responsibilities:

  • Integration & maintenance of the Quality Management System in accordance with ISO 13485 & MEDDEV 93/42/EEC.
  • Support other departments to ensure that products manufactured meet customer requirements.
  • Ensuring that product introductions & change controls are effectively managed in accordance with ISO 13485 & MEDDEV 93/42/EEC.
  • Review and release of batch paperwork for product release.
  • Participation in the new product introductions programmes to ensure that they are effectively introduced in accordance with ISO 13845.
  • Generation of product technical files in accordance with MEDDEV 93/42/EEC.
  • Maintenance of the customer complaint investigation process, MEDDEV 93/42/EEC vigilance requirements and assisting in product recalls & preventive action programme.
  • Participation in routine Failure investigation & process trouble-shooting.
  • Maintenance of plant continuous process improvement programmes.
  • Participation in the Corrective Action Programme.
  • Participation in the Internal Quality Audit Programme.
  • Co-ordination & maintenance of the Calibration Programme.
  • Co-ordination & maintenance of the Validation Programme.
  • Vendor Assessment liaison & Maintenance.

Requirements:

  • BSc. in Manufacturing or Quality with emphasis on Medical Device or Biomedical.
  • 2-3 years’ experience as Quality/Validation Engineer in Medical Device or Pharmaceutical environment.
  • Minitab experience preferred
  • 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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