Supplier Quality Engineer

Responsibilities arrow_right Prepare, maintain and review supplier quality procedures to ensure compliance with customer and regulatory requirements. Complete the supplier performance review process. Generate appropriate performance metrics, and drive resolution of issues Implement and maintain the supplier corrective action request (SCAR) process. Develop and execute the global supplier audit schedule. Travel to supplier facilities to conduct audits and to enhance effectiveness and capabilities and complete relevant audit reports and follow up. Process and implement supplier changes through the supplier change notification process Support Supply Chain Manager in the development of new suppliers or existing suppliers of new components, to improve reliability and/or reduce cost Lead briefings and technical meetings for internal and external representatives Assist with and complete material compliance requirements related to REACH, RoHS, Prop 65, EU MDR ,CLP etc. Review and update of material safety data sheets (MSDS's) as required. Participation in the Plant Corrective Action Programme Participation in the Internal Quality Audit Programme Ensuring that product introductions & changes are effectively managed in accordance with the requirements of ISO 13485, MD 93/42/EEC & MDR 2017/745. Participation in the new product introductions programmes to ensure that they are effectively introduced in accordance with the requirements of ISO 13845. Qualifications arrow_right Required: Third level qualification in Engineering/Manufacturing/Quality with emphasis on Medical Device Strong CAPA experience Demonstrated excellent organizational skills and ability to work on own initiative essential Desirable: 2-3 years' experience as Quality Engineer in Medical Device/Pharmaceutical Environment is desirable Strong working knowledge of FDA and ISO Quality systems for Medical device companies desirable Fully PC literate, use/knowledge of Minitab would be beneficial.