Quality Assurance Engineer

Our client in Leitrim is seeking a Quality Assurance Engineer to join their team,

Your tasks

  • Integration & Maintenance of the Quality Management System with all processes in accordance with the requirements of ISO 13485 & MEDDEV 93/42/EEC.
  • Deputising for the Management Representative in their absence.
  • Provision of support to all departments to ensure that products manufactured meet customer requirements.
  • Ensuring that product introductions & change controls are effectively managed in accordance with the requirements of 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 the requirements of ISO 13845.  Generation of Product Technical Files & associated studies in accordance with MEDDEV 93/42/EEC when appropriate.
  • Maintenance of the Customer Complaint investigation process, MEDDEV  93/42/EEC vigilance requirements and assisting in product recalls & corrective/ preventive action programme.
  • Participation in routine Failure Investigation & process trouble-shooting.
  • Maintenance of plant Trending & Continuous process improvement programmes.
  • Participation in the Plant Corrective Action Programme.
  • Participation in the Internal Quality Audit Programme.
  • Co-ordination & maintenance of the Calibration Programme.
  • Co-ordination & maintenance of the Validation Programme.
  • Maintenance of the Plant Environmental & Cleaning/ Housekeeping Programme, including sub-contractor maintenance.
  • Maintenance of the Plant Laundry & Rodent Control Sub-Contractors to required standards.
  • Vendor Assessment liaison & Maintenance
  • Ensuring that quality system & product requirements are included in the plant Training Programmes designated trainer.

Our expectations

  • Third level qualification in Engineering/Manufacturing/Quality with emphasis on Medical Device/Biomedical.
  • 2-3 years’ experience as Quality/Validation Engineer in Medical Device/Pharmaceutical environment.
  • Fully PC literate.

For further information please contact Sylvester on 094 90 29944 or email CV to Sylvester@arconrecruitment.com

Your Recruitment Consultant is Sylvester Jennings

Sylvester Jennings