Job Title:Senior Quality EngineerReporting To:Quality ManagerRole OverviewThe Senior Quality Engineer will play a key role in driving compliance, supporting new product introductions (NPI), and maintaining the effectiveness of the Quality Management System (QMS). This position requires strong technical knowledge, leadership ability, and hands-on experience within the medical device sector.Key ResponsibilitiesDrive compliance and ensure achievement of organisational quality objectives.Support the implementation and continuous improvement of NPI processes and systems to enhance quality, efficiency, and product safety.Implement and maintain Lean Product Development practices.Develop and execute test strategies, methods, and validation protocols (including sterilisation, packaging, biocompatibility, and process validations).Support the Quality Management System, including management reviews, design control, change control, CAPA, risk management, and document control.Ensure the QMS remains compliant with ISO and FDA standards and other applicable regulations.Collaborate closely with project management teams and customers to successfully deliver projects that meet or exceed expectations.Mentor, develop, and support engineers and technicians, providing guidance, coordination, and feedback as needed.Support internal, supplier, customer, and regulatory audits, as well as certification activities.RequirementsDegree in a science, engineering, or technical discipline.Minimum of 5+ years' experience within the medical device industry.Proven experience establishing and maintaining all aspects of a Quality Management System.Experience with cleanroom management, validation processes, and sterilisation validation is advantageous.Demonstrated ability to build, lead, and motivate cross-functional teams.Strong communication and stakeholder management skills, including experience engaging with senior leadership and customers.Experience in project environments and manufacturing product release processes is highly desirable.Agile, innovative, and proactive with strong problem-solving abilities.Experience with CAPA, risk management, document control systems, and NPI processes preferred.