Quality Systems Technical Assistant to join a well-established Quality Systems department within a leading organisation who design and develop medical devices. This is a varied role, providing technical support to ensure quality standards and regulatory requirements are consistently met. The successful candidate will play a key role in supporting documentation, change control, non-conformance management, product release, training systems and wider quality assurance activities. Key Responsibilities * Progress and monitor changes within the Product Lifecycle Management (PLM) system in line with established quality procedures. * Manage documentation and support control processes to maintain compliance. * Assist in quality activities relating to corrective and preventive actions (CAPA), non-conformance reports (NCR) and complaints. * Support the Quality Systems team in reviewing documentation for products manufactured or serviced to ensure regulatory compliance. * Maintain and oversee the Electronic Training System to ensure quality requirements are met. * Provide guidance to design and manufacturing teams on the Change Control process to minimise future risk. * Generate reports for management to monitor system performance. * Contribute to improvements within the Quality System to drive efficiency while remaining compliant with industry regulations. * Support and deliver training across the business to raise awareness of quality requirements. Skills & Experience Required * GCSE level qualification (Science/Engineering/Quality) or equivalent proven experience. * At least 1 year’s experience in a regulated industry such as medical devices, pharmaceuticals, or similar. * Knowledge of electronic change control systems and experience with investigational quality activities. * Familiarity with ISO13485, MDR 93/42/EEC and FDA QSR Part 820 (desirable). * Competent with Microsoft Office (Word, Excel) and MRP systems. * Strong organisation and prioritisation skills, with the ability to manage multiple tasks. * Excellent communication skills, both written and verbal. * Good attention to detail with accurate record-keeping abilities. * A proactive team player who works with integrity and accountability. Benefits * Hybrid working model (typically 2 days from home, 3 days on-site). * Annual bonus scheme. * Competitive pension contributions. * Life assurance (4x salary). * Private medical insurance. * BUPA dental cover. * 25 days annual leave plus bank holidays. * Employee Assistance Programme