Responsibilities arrow_right This involves but is not limited to: 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
