Quality & Regulatory Engineer in Houghton-Le-Spring

Quality & Regulatory Engineer Location: Durham Contract: Full-time, temporary (12–14 months) Working Hours: Shift work may be required (7am–3pm / 3pm–11pm) About the Role We are recruiting for a Quality & Regulatory Engineer to join a manufacturing business based in Durham, supporting quality assurance, product compliance and regulatory activities within a medical device manufacturing environment. This is an excellent opportunity for someone with experience in quality engineering, quality management systems or regulatory affairs who is looking to develop their expertise within a regulated manufacturing setting. You will play an important role in ensuring products meet the required quality, safety and regulatory standards, with a particular focus on medical device production and cleanroom operations. Key Responsibilities * Support the development, implementation and maintenance of quality control systems and procedures. * Ensure products meet relevant quality, safety and regulatory requirements. * Support regulatory affairs activities relating to medical devices. * Assist with compliance against ISO 13485 and EU Medical Device Regulation (MDR) requirements. * Prepare, review and maintain technical documentation and production procedures. * Conduct product testing, inspections and evaluations to verify compliance with specified requirements. * Investigate product non-conformances and manufacturing issues, identifying root causes and implementing corrective and preventive actions (CAPA). * Collect and analyse quality data to identify trends and opportunities for improvement. * Support internal and external quality audits. * Provide guidance and training to production personnel on quality standards and procedures. * Support medical device manufacturing activities, particularly within cleanroom environments. * Work closely with production and quality teams to promote continuous improvement and maintain compliance. About You To be considered for this position, you will ideally have: * A degree in Engineering, Life Sciences or a related discipline. * At least one year of experience in medical device regulatory affairs or quality management systems. * An understanding of quality assurance, quality control and regulatory compliance. * Strong analytical and problem-solving skills, with the ability to investigate quality issues and identify corrective actions. * Good attention to detail and the ability to maintain accurate technical documentation. * Strong communication skills and the ability to work collaboratively with production and quality teams. Desirable experience: * Knowledge of ISO 13485 quality management systems. * Previous exposure to EU MDR compliance. * Experience with technical documentation within a regulated manufacturing environment. * Exposure to medical device production, cleanroom operations, product validation or quality auditing. The Opportunity This is a full-time temporary opportunity expected to last approximately 12–14 months, providing the opportunity to gain valuable experience within a regulated medical device manufacturing environment. The successful candidate will work closely with the Quality Assurance Manager, supporting quality systems, regulatory compliance and production activities. Apply Now If you have a background in quality engineering, medical devices or regulatory affairs and are looking for your next opportunity, we would like to hear from you. Submit your CV today to be considered