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Are you an experienced Quality Assurance professional looking to advance your career with a leading organisation in life-changing healthcare technology? We are seeking a Quality Engineer to join our Quality Assurance team based at our manufacturing site in Witney. In this crucial role, you will be responsible for driving the monitoring, compliance, and continuous improvement of the Quality Management System (QMS). You will act as a Subject Matter Expert (SME) for site-level and divisional projects, ensuring that all product development, processing, validation, and manufacturing processes meet strict regulatory standards.
Job Responsibility
Oversee review, approval, and impact assessment of changes or corrections to documentation, processes, or systems
Act as key authority making critical compliance and quality decisions on products during development, validation, manufacturing, and packaging
Lead and project manage cross-functional team activities using risk management tools
Partner closely with internal departments to safely achieve project milestones
Directly manage, monitor, and assist day-to-day activities of direct reports
Step up as SME during internal and external quality audits and high-level cross-functional meetings
Requirements
Regulated industry background in development or manufacture of regulated products (such as medical devices, pharmaceuticals, or healthcare manufacturing)
solid understanding and working knowledge of cGMP and/or ISO Quality System requirements (e.g., ISO 13485)
leadership capabilities, experience with or strong desire to manage direct reports, mentor team performance, and run training programs
secondary level education including English and Maths (or equivalent qualification)
strong communication skills, cross-functional relationship management, proficiency using risk management tools