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