Quality Assurance Engineer with experience working as a Quality/Validation Engineer in Medical Device or Pharmaceutical environment required for permanent role in Co. Leitrim. You will be responsible for the maintainence of the organisations quality management system.
- Integration & maintenance of the Quality Management System in accordance with ISO 13485 & MEDDEV 93/42/EEC.
- Support other departments to ensure that products manufactured meet customer requirements.
- Ensuring that product introductions & change controls are effectively managed in accordance with 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 ISO 13845.
- Generation of product technical files in accordance with MEDDEV 93/42/EEC.
- Maintenance of the customer complaint investigation process, MEDDEV 93/42/EEC vigilance requirements and assisting in product recalls & preventive action programme.
- Participation in routine Failure investigation & process trouble-shooting.
- Maintenance of plant continuous process improvement programmes.
- Participation in the Corrective Action Programme.
- Participation in the Internal Quality Audit Programme.
- Co-ordination & maintenance of the Calibration Programme.
- Co-ordination & maintenance of the Validation Programme.
- Vendor Assessment liaison & Maintenance.
- BSc. in Manufacturing or Quality with emphasis on Medical Device or Biomedical.
- 2-3 years’ experience
- Minitab experience preferred
- Must be authorised to work in Ireland.
Please contact Emer Smith to discuss in confidence