IM Med is currently recruiting for a full-time Quality Manager to join our Quality & Regulatory team, based in Waterbeach, Cambridge, and to take responsibility for the Quality Management System (QMS) covering the requirements of EU Medical Devices Regulations 2017/745/EU, UK Medical Device Regulations (2002) (including applicable parts of Medical Devices Directive 93/42/EEC), and ISO 13485:2016. As the industry leading decontamination specialist, our QMS underpins the design, development and manufacture of chemical disinfectants and cleaning agents for use on invasive medical devices; in addition to the sale, supply, maintenance, repair, commissioning and periodic testing of infection control equipment. The sale and supply of consumables and parts to support the aforementioned activities. We prioritise service excellence, quality products and customer choice, enabling healthcare providers to focus on patient safety. We provide a complete decontamination strategy including an extensive portfolio of decontamination products, solutions and services, including equipment, technical services, consumables and compliance support. We are committed to our mission to provide excellence, quality and choice; and are proud of the team we have built to help us deliver this mission. As Quality Manager you will manage the iM Med quality team and will promote Continuous Improvement within the QMS and the wider company, working closely with the wider leadership team and external Quality Consultants. You will ensure that the team consistently produce high quality output. Quality Manager- Key Responsibilities: Lead quality and Continuous Improvement initiatives. Lead and provide direction and objectives for the QA team ensuring processes within the QMS are maintained and improvements made. Ensure internal audits of the Quality Management Systems are carried out to maintain continued compliance with appropriate standards and regulations and make any recommendations for improvement. Support notified body audits and 3rd party audits and ensure all findings are followed up and closed out in a timely manner. Provide progress reports on Departmental KPIs for Senior Management meetings in order to report status and recommend areas for improvement. Support new product development ensuring quality plans, specifications, training and full validations are complete and ensure a smooth handover to production. Ensure business operations is fully supported to ensure manufacturing quality issues (NCRs) are dealt with and closed out in a timely manner. Ensure associated documentation is completed and follow up until actions and documentation including database records are closed out. Manage corrective and preventive actions (CAPAs) and lead CAPA teams as necessary. Ensure validation of new materials or materials changes through full validation, training and monitoring. Lead Continuous Improvement (CI) projects or assist with Continuous Improvement initiatives and communicate progress to CI teams with regards to key KPIs including waste and customer complaints. Manage change control and ensure the document control system is maintained. Establish supplier quality performance criteria and monitor supplier performance, including assessing suppliers product specifications and approval of suppliers through site visitation and audit. Ensure good collaboration with suppliers and the follow up and closure of supplier quality issues Quality Manager-Education/Experience required: A Quality professional, educated to degree level (or equivalent), with considerable quality experience within a medical device related environment. Knowledge of the Medical Device Directive 93/42/EEC and experience creating and maintaining CE technical files. Lead Auditor or trained as an internal auditor. Experience working in the medical device or pharmaceutical industry. Computer literate with good working knowledge of Microsoft Word, Excel, PowerPoint. We offer an excellent benefits package and are committed to ongoing skills development. If the Quality Manager role sounds like a good fit, please forward your CV today. If your experience matches our criteria you will be contacted to arrange an informal telephone conversation in the first instance, with the next stage involving a more formal interview and skills competency questions.