1 of 1 ISO 13485 Jobs in Romsey

Quality Assurance within the medical device industry. Strong knowledge of medical device design, development and Quality Management Systems (QMS). Working knowledge of ISO 13485, FDA 21 CFR Parts 820 & 11, and EU MDR (2017/745). Experience leading internal, external and regulatory audits. Understanding of risk … management principles (ISO 14971 desirable) and regulatory compliance requirements. Proven ability to lead CAPA and root cause investigations using recognised problem-solving methodologies. Experience driving continuous improvement and implementing quality improvement initiatives. Strong leadership, communication and stakeholder management skills, with the ability to influence cross-functional teams. Excellent analytical ...