This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
We are seeking a skilled and adaptable Quality Engineer to join a global medical device company based in Witney. This is a highly collaborative, cross-functional role where you will support a range of processes from R+D to clinical groups to transport and sterilisation. We are looking for a professional who has interest in supporting Design Validation or Test Method Validation (TMV), who can make critical quality and compliance decisions during product development, validation, and testing. Acting as a Subject Matter Expert (SME), you will manage project activities to ensure our processes meet both business and customer needs flawlessly.
Job Responsibility
Make definitive Quality and Compliance decisions on products throughout development, validation, processing, and testing phases
Project-manage cross-functional activities to agreed timelines, utilising appropriate risk management tools to prioritise efforts and safeguard quality
Maintain successful, collaborative relationships with cross-functional departments, including R&D, Technical, Engineering, Operations, and Regulatory Affairs to achieve project milestones
Review, approve, and assess the impact of changes or corrections to documentation, processes, or systems to ensure effective and compliant QMS procedures
Act as the Subject Matter Expert (SME) during audits, cross-functional meetings, and site/divisional level projects
Ensure all record completion strictly adheres to defined procedures and quality standards, securing and storing data appropriately
Maintain safe working environments by supporting Environment, Health, and Safety (EHS) performance and ensuring all business behaviours align strictly with the corporate Code of Conduct
Requirements
Proven experience as a Quality Engineer with a dedicated focus on design validation or test method validation
Prior experience in the development and/or manufacture of regulated products, demonstrating a strong familiarity with cGMP and/or ISO Quality System requirements
Demonstrated ability to build and maintain relationships across multiple engineering and technical disciplines
Strong technical understanding of validation principles, statistics, and risk management tools
Secondary level education including English and Maths (or equivalent)
Relevant Degree or equivalent qualification
What we offer
Standard 37.5-hour work week with a dependable Monday to Friday schedule