We are supporting a globally recognised medical device manufacturer in South Wales in the search for a Head of Quality to join its senior leadership team and drive organisational quality strategy. This is a multinational healthcare organisation with a strong global presence, delivering innovative products used by patients and healthcare professionals worldwide. As Head of Quality, you will play a critical role in shaping the organisation’s quality strategy, ensuring regulatory compliance, and driving continuous improvement across a multi-site manufacturing environment. You will work closely with cross-functional leadership teams to maintain high standards of product quality, operational excellence, and patient safety across the full product lifecycle. Your responsibilities as the Head of Quality will include: Developing and delivering the organisation’s Quality Strategy aligned with business objectives and regulatory requirements Leading and developing multi-site Quality Assurance and Quality Control teams, embedding a strong quality culture Owning and continuously improving the Quality Management System (QMS) in line with ISO 13485 requirements Ensuring ongoing audit readiness across manufacturing sites, including internal, customer, and Notified Body audits Driving effective CAPA, change control, and quality governance processes to support compliance and improvement Establishing and monitoring quality KPIs to improve right-first-time performance and operational efficiency Partnering with Engineering, Operations, and R&D teams to ensure processes and products are compliant by design Supporting product lifecycle compliance and coordinating quality input into product and process changes Providing quality performance reporting and governance updates to senior leadership teams To be successful as the Head of Quality, you will need to demonstrate: Significant senior Quality leadership experience within medical devices or a similarly regulated industry Strong knowledge of ISO 13485 and experience managing an effective Quality Management System Proven experience leading audits, maintaining audit readiness, and managing CAPA systems Experience working with Notified Bodies and external regulatory stakeholders Strong leadership, communication, and stakeholder management capabilities The ability to drive continuous improvement within complex manufacturing environments In addition, the following will be advantageous for a Head of Quality: Experience operating within an MDSAP environment Internal or external auditor certification Continuous Improvement or Operational Excellence experience Experience collaborating closely with Regulatory Affairs functions Head of Quality | Quality Director | Senior Quality Manager | Medical Devices | ISO 13485 | QMS | CAPA | Audit Readiness | Regulatory Compliance | Quality Assurance | Continuous Improvement | South Wales Jobs | Hybrid Working Job ID: 97831