Integration & Maintenance of the Quality Management System with all VISTAMED processes in accordance with the requirements of ISO 13485, MDD 93/42/EEC & MDR 2017/745.
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, 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 & 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 & 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
Ensuring that quality system & product requirements are included in the plant Training Programmes designated trainer
Qualifications arrow_right
Required:
Third level qualification in Engineering / Manufacturing / Quality with emphasis on Medical Device / Biomedical. Minimum Bachelor’s degree in a Science / Engineering / Quality related discipline.
2-3 years’ experience as Quality/Validation Engineer in Medical Device/Pharmaceutical Environment
An Associate position may exist where there is limited experience and will be assigned to an experienced Engineer.
A Senior position may exist for a minimum of 6 years` experience
Fully PC literate, use/knowledge of Minitab would be beneficial
