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QA Engineer

Job Title: QA Engineer
Contract Type: Permanent
Location: Leitrim
REF: 88401
Job Published: over 1 year ago

Job Description

Contact: Cliona O'Malley
Telephone: 091730022

QA Engineer
Our client, a medical device company in Leitrim are currently looking to recruit a QA Engineer for their site.

Required Qualifications/Experience/Skills:
  • 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, use/knowledge of Minitab would be beneficial.
Duties/ Accountabilities (incl. Deputation):
This involves but is not limited to:
  • 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.

For further information on this QA Engineer role in Leitrim please contact Cliona O'Malley on 091730022 /
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