Our client, a medical device company in Leitrim are currently looking to recruit a QA Engineer for their site.
- 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.
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 / firstname.lastname@example.org
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