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 13485, and other applicable regulatory standards. * Participate in internal and external audits and support audit readiness activities. * Support Clean Room manufacturing operations and ensure compliance with applicable quality and regulatory requirements. * Contribute to the continual improvement of the Quality Management System (QMS). Required * Degree in Engineering, Life Sciences, or a related discipline. * Minimum 1 year of experience in medical device regulatory affairs, quality assurance, or quality management systems. * Experience supporting EU MDR compliance and/or ISO 13485 Quality Management Systems. * Strong analytical and problem-solving skills. * Good written and verbal communication skills. Desirable * Experience writing technical and regulatory documentation. * Six Sigma qualification or equivalent continuous improvement training. * Experience within a medical device manufacturing environment. * Experience supporting Clean Room production activities. * Knowledge of CAPA, risk management, and validation activities