Quality and Regulatory Engineer

Quality and Regulatory Engineer Our client, based in Houghton Le Spring, is recruiting for a Quality and Regulatory Engineer for a maternity cover. Hours are 8.00am - 4.00pm Monday to Friday but may shift to a two-shift system later on. Key Responsibilities Support the design, development, manufacture, testing, and regulatory compliance of medical devices and related products. Develop, implement, and maintain effective quality control systems and processes. Create and manage production protocols, procedures, and quality documentation. Ensure products consistently meet quality, safety, and regulatory requirements. Train and support production personnel in the application of quality standards and procedures. Monitor quality performance and drive continuous improvement initiatives across manufacturing operations. Collect, analyse, and report quality data to identify trends and improvement opportunities. Investigate product non-conformances and customer complaints, implementing appropriate corrective and preventive actions (CAPA). Troubleshoot manufacturing and design-related quality issues to improve product performance and process capability. Conduct testing, inspection, and evaluation of medical devices and other products to verify compliance with specifications and performance requirements. Support validation and verification activities as required. Assist the Quality Assurance Manager with medical device regulatory affairs activities. Support compliance with EU MDR, ISO ..... full job details .....