Engineering - Quality Engineer

Are you passionate about quality and precision? Join our client with this engineering role and help ensure top-tier standards every day.Proclinical is seeking a skilled engineer to join a dynamic team in Cambridge, UK. In this role, you will provide expertise in design control and risk management for medical devices and combination products throughout their lifecycle. You will collaborate with cross-functional teams to ensure compliance with quality and regulatory standards while supporting clinical trials and commercial licensures. This is an exciting opportunity to contribute to innovative biotherapeutic solutions. Responsibilities:Lead design control and risk management activities for combination product development programs.Author, review, and maintain design history files and risk management documentation.Facilitate risk management activities with external design companies and manufacturing facilities.Ensure compliance with internal and external quality and regulatory standards.Support design validation processes, including human factors engineering assessments.Assess external design companies and suppliers for quality systems and capabilities.Investigate device design and manufacturing issues from clinical trials and commercial use.Contribute to regulatory submission data and content for assigned projects.Support internal and external audits of the Quality Management System.Identify and implement strategies to improve combination product systems. Key Skills and ..... full job details .....