Job Title:
Senior Quality Engineer
Job Description:
We are seeking a highly skilled and experienced Senior Quality Engineer to join our organization. As a Senior Quality Engineer, you will play a key role in ensuring the quality of our products and processes.
1. Integration & Maintenance of the Quality Management System with all processes in accordance with ISO 13485, MDD 93/42/EEC & MDR 2017/745 requirements.
2. Deputising for the Management Representative in their absence.
3. Providing support to all departments to ensure that products manufactured meet customer requirements.
4. Ensuring that product introductions & change controls are effectively managed in accordance with ISO 13485, MDD 93/42/EEC & MDR 2017/745 requirements.
5. Review and Release of batch paperwork for Product release.
6. Participation in new product introductions programmes to ensure effective introduction in accordance with ISO 13485. Generation of Product Technical Files & associated studies in accordance with MDD 93/42/EEC & MDR 2017/745 when appropriate.
7. Maintenance of Customer Complaint investigation process, MDD 93/42/EEC & MDR 2017/745 vigilance requirements assisting in product recalls & corrective/preventive action programme.
8. Participation in routine Failure Investigation & process trouble-shooting.
9. Maintenance of plant Trending & Continuous process improvement programmes.
10. Participation in Plant Corrective Action Programme.
11. Participation in Internal Quality Audit Programme.
12. Co-ordination & maintenance of Calibration Programme.
13. Co-ordination & maintenance of Validation Programme.
14. Maintenance of Plant Environmental & Cleaning/Housekeeping Programme, including sub-contractor maintenance.
15. Maintenance of Plant Laundry & Rodent Control Sub-Contractors to required standards.
16. Vendor Assessment liaison & Maintenance.
17. Ensuring that quality system & product requirements are included in the plant Training Programmes designated trainer.
18. Adhering to Plant Safety requirements and Health & Safety requirements relating to work, assuming responsibility for aspects of OH&S System over which control exists to ensure health and safety of self and others.
Qualification and Skills:
* 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. Minimum Bachelor's degree in Science / Engineering / Quality related discipline.
* Associate position may exist where there is limited experience and will be assigned to an experienced Engineer.