Manufacturing Quality Lead - Medical Devices

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Provides functional quality oversight across the Cardiff medical device value stream, ensuring manufacturing activities meet applicable Quality Management System, regulatory, customer and internal requirements. Working with a high degree of autonomy, the role drives quality performance, resolution of significant issues and effective management of product and process risk. This position reports to the Senior QA/QC Manager, sits within the Quality function in Cardiff, and is an on‑site role with no direct reports.

• Monitor manufacturing quality performance using nonconformance, complaint, CAPA, right‑first‑time, process capability and Cost of Quality data to identify risk, establish priorities and drive improvement.
• Provide Quality guidance and independent challenge across the medical device value stream, partnering with Operations and Engineering to maintain effective manufacturing controls and compliance with ISO 13485 and applicable requirements.
• Drive effective resolution of nonconformances, deviations, complaints and CAPAs, ensuring appropriate containment, robust investigation, evidence‑based conclusions and sustainable corrective action.
• Provide Quality governance for manufacturing changes, equipment and process validation, product and process transfers, PFMEA and manufacturing risk management.
• Make manufacturing quality decisions within delegated authority, escalating significant or systemic product, process or compliance risks with clear recommendations.
• Support audit and inspection readiness, ensuring manufacturing quality evidence, responses and remediation actions are robust and delivered to agreed timelines.
• Drive cross‑functional improvement of manufacturing processes and controls, influencing accountable stakeholders to deliver agreed actions and sustained improvements.

• Degree, or equivalent experience, in Engineering, Science, Quality or a related technical discipline.
• Typically 8+ years’ relevant experience in medical device, life sciences, pharmaceutical or another regulated manufacturing environment, with substantial manufacturing Quality experience.
• Strong practical knowledge of ISO 13485 and its application to manufacturing operations, including investigations, CAPA, change control, validation and risk management.
• Strong analytical and risk‑based decision‑making capability, with experience using manufacturing and Quality data to identify trends, prioritise issues and improve performance.
• Demonstrated ability to operate autonomously, provide functional direction and constructive challenge, and influence senior…