Quality Engineer

Found in: beBee jobs IE - 1 week ago


County Roscommon, Ireland Cpl Full time

Quality Engineer

My client, a global partner for the design, development and manufacture of medical devices, is looking to hire a Quality Engineer on a permanent basis.

This is a permanent onsite role, based in Carrick-on-Shannon,

Responsibilities

  • Integration & Maintenance of the Quality Management System, in accordance with ISO Standards 13485, MDD 93/42/EEC & MDR 2017/745.
  • Ensure that products manufactured meet customer requirements
  • Ensuring that product introductions & change controls are effectively managed in accordance with the requirements of ISO 13485, MDD 93/42/EEC & MDR 2017/745.
  • 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
  • Generation of Product Technical Files & associated studies in accordance with MDD 93/42/EEC & MDR 2017/745 when appropriate.
  • Maintenance of the Customer Complaint investigation process, MDD 93/42/EEC & MDR 2017/745 vigilance requirements assisting in product recalls & corrective/ preventive action programme
  • Participation in routine Failure Investigation.
  • 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

Requirements

  • Third level qualification in Engineering / Manufacturing / Quality with emphasis on Medical Device / Biomedical. Minimum bachelor's degree in a Science / Engineering / Quality related discipline
  • 2+ years' experience as Quality or Validation Engineer in Medical Device/Pharmaceutical Environment
  • Knowledge of Minitab.

For more information, please contact

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