Quality Assurance Manager

Romsey, Hampshire Zenovo Job Title: Quality Assurance Manager Location: Romsey (On-Site Working)  Salary: £60,000 - £70,000 (Depending on Experience)  Please Note: All Applicants must have the right to work in the UK without the need for VISA sponsorship now or in the future Overview: A successful candidate will act as the Quality Management Representative, reporting to senior leadership and ensuring the ongoing effectiveness, compliance, and continuous improvement of the Quality Management System (QMS). They will provide expert guidance across product development, manufacturing, and operational teams to maintain compliance with applicable medical device regulations and quality standards. This hands-on leadership role will champion a culture of quality, regulatory excellence, and continuous improvement across the organisation. Key Responsibilities: Lead the Quality Assurance function and drive quality and regulatory compliance across the organisation. Maintain and continuously improve the Quality Management System (QMS) to meet applicable regulatory and industry standards. Act as the Quality Management Representative and ensure ongoing regulatory compliance and audit readiness. Promote a culture of quality, risk management and continuous improvement across all business functions. Lead CAPA, internal audits, supplier quality and external audit activities. Monitor quality performance, analyse trends and implement improvement initiatives. Provide quality and regulatory support throughout product development, manufacturing and operational activities. Develop, coach and lead the Quality team while maintaining effective relationships with regulators, customers and external stakeholders. Required Skills & Experience: Proven experience in 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, organisational and project management skills, including supplier and customer quality management