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