Well established manufacturing and distribution client requiring 12 - 18 month support, role has start date of January 2026. The Lead Document Controller / Auditor reports into t he Quality Manager and the direction of the Technical Manager and PRRC & Quality & Compliance, the Document Control Lead will be responsible for the efficient management, organisation and distribution of company documents including all Quality System documentation, Change Requests, Corrective and Preventive Actions, Declarations of Conformity and various registers. Role and Responsibilities Creation (with input from others), management and processing of Change Requests affecting all areas of the Quality Management System including product changes, procedures, work instructions, forms and other related documents. Ensure that all documents comply with company standards and regulatory requirements, managing revisions, approvals, archival, and distributions as necessary Manage the Training program for the Quality Management System and ensure training is completed in a timely manner Input and manage data in electronic control systems such as Excel spreadsheets, ERP system or Quality Management software as required Establish and ensure adherence to annual Internal Audit schedule and perform audits as assigned. Create Audit Agendas and Audit Reports to communicate results of audits with department managers. Create action items from Audit findings and follow-up to ensure completion in timely manner. Assist in preparing documentation for internal and external audits and ensure compliance with company and regulatory requirements and participate in annual ISO audit Support the Corrective and Preventive Action Program, working with stakeholders to ensure documentation, containment, investigation, action plan implementation and verification of effectiveness is completed in a timely manner. Produce regular reports and trending analysis of quality assurance performance and Key performance indicators as required and present in annual Management Review meeting Maintain master product list with all active part numbers and their related attributes Collect Post Market Feedback information from various sources and update all affected Technical File documents such as PMS Plans, Reports, Risk Management Files, Clinical Evaluation Plans and Reports, Technical Documentation Summaries Maintain Supplier Management Files including creating and updating Quality Agreements and Certifications. Also collecting Supplier Scorecards. Prepare all regulatory submission documentation including MHRA product spreadsheets. Prepare monthly EU Export submission report,reconcile products listed and provide label verifications Assist in creating and maintaining Manufacturing Specifications and Kitting Instructions Day to day duties will include assigning numbering and labelling documents for identification and reference, scanning, copying and distributing documents for team members and stakeholders Collating necessary documents for submission to external stakeholders and customers as required Education& Experience An educational background with a Higher pass in English and a Business based subject would be preferable Previous experience in Quality & Regulatory Compliance Document Control experience Good working knowledge of Microsoft Windows-based software packages, including Excel spreadsheets, Outlook email and Word processing documents. Experience in Medical Device manufacturing environment ISO13485 experience Internal Auditor experience in medical devices The ability to work effectively in a team environment and to process deadlines A strong customer service focus and the ability to build effective working relationships with employees and external stakeholders Self-motivated,confident and a good communicator with the ability to adapt to new systems and processes Effective time management skills Excellent accuracy and attention to detail and an orderly approach to processing Ability to identify areas for improvement of processes and make recommendations based on this