Manufacturing Quality Lead - Medical Devices

Job description

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cytiva, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies. At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career. Learn about the Danaher Business System which makes everything possible. The Manufacturing Quality Lead, Medical Devices 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. What you will do: 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. Who you are: 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 cross-functional stakeholders without direct reporting authority. Strong written and verbal communication skills, with the ability to translate complex Quality issues into clear decisions, recommendations and escalation. Demonstrated ability to manage multiple significant Quality priorities and drive timely delivery in a regulated manufacturing environment. It would be a plus if you also possess previous experience in: Lead auditor or internal auditor training for ISO 13485, with experience supporting notified body, regulatory or customer audits. Experience with medical-device manufacturing transfers, New Product Introduction, process validation, supplier quality or complaint investigation. Recognised quality, regulatory, Lean / DBS or Six Sigma qualification, with practical experience improving process capability, right-first-time performance or Cost of Quality. Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com.