Job Title: Senior Quality Engineer
About This Role:
* This position is responsible for ensuring the quality of our products meets customer requirements.
* The successful candidate will have a deep understanding of ISO 13485, MDD 93/42/EEC & MDR 2017/745.
Key Responsibilities:
1. Integration and Maintenance of the Quality Management System with all processes in accordance with regulatory requirements.
2. Provision of support to all departments to ensure product quality.
3. Review and Release of batch paperwork for Product release.
4. Participation in new product introductions programmes.
5. Maintenance of the Customer Complaint investigation process.
6. Participation in routine Failure Investigation & process trouble-shooting.
7. Maintenance of plant Trending & Continuous process improvement programmes.
8. Co-ordination & maintenance of the Calibration Programme.
9. Co-ordination & maintenance of the Validation Programme.
10. Maintenance of plant Environmental & Cleaning/Housekeeping Programme.
Requirements:
* 2-3 years' experience as Quality/Validation Engineer in Medical Device/Pharmaceutical Environment.
* Third level qualification in Engineering/Manufacturing/Quality with emphasis on Medical Device/Biomedical.
* An Associate position may exist where there is limited experience and will be assigned to an experienced Engineer.