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QA Engineer (Validation) - Leitrim

Job Title: QA Engineer (Validation) - Leitrim
Contract Type: Permanent
Location: Leitrim
Industry:
REF: 90422
Job Published: 11 months ago

Job Description

Contact: Bimi Felix
Email: bimi@hero.ie
Telephone: 0868395533

QA Engineer (Validation)
Our client, a medical device company in Leitrim are currently looking to recruit a QA Engineer (Validation) 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 company 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.
  • Ensuring that product introductions & change controls are effectively managed in accordance with the requirements of ISO 13485 & MDD 93/42/EEC.
  • 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 MDD 93/42/EEC when appropriate.
  • Completion of Validation Programme - Risk Analysis, VMP, IQ's, OQ's, PQ's as required according to procedure QAP 030 and other related procedures
For further information on this QA Engineer (Validation) role in Leitrim please contact Bimi Felix on 0868395533 / bimi@hero.ie
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