Quality Engineer
Cpl Group
- Roscommon
- Permanent
- Full-time
- Integration & Maintenance of the Quality Management System, in accordance with ISO Standards 13485, MDD 93/42/EEC & MDR 2017/745.
- Ensure that products manufactured meet customer requirements
- Ensuring that product introductions & change controls are effectively managed in accordance with the requirements of ISO 13485, MDD 93/42/EEC & MDR 2017/745.
- 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 13485.
- Generation of Product Technical Files & associated studies in accordance with MDD 93/42/EEC & MDR 2017/745 when appropriate.
- Maintenance of the Customer Complaint investigation process, MDD 93/42/EEC & MDR 2017/745 vigilance requirements assisting in product recalls & corrective/ preventive action programme
- Participation in routine Failure Investigation.
- 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
- Third level qualification in Engineering / Manufacturing / Quality with emphasis on Medical Device / Biomedical. Minimum bachelor's degree in a Science / Engineering / Quality related discipline
- 2+ years' experience as Quality or Validation Engineer in Medical Device/Pharmaceutical Environment
- Knowledge of Minitab.