Senior Quality Manager

1 week ago


Cornwall, United Kingdom Real Full time

Our client a global Medical Device manufacturing company are looking for a Senior Quality Manager to join an existing team reporting to the Head of QA. The company produce equipment, consumable medical devices and general laboratory equipment utlised in surgical settings and fem tech. This is a cross functional role where the chosen candidate will manage a team whilst working with internal and international teams/departments.As the Senior Quality Manager, you will be responsible for overseeing the daily quality operations at the manufacturing site, ensuring regulatory compliance, implementation, and consistent performance of quality requirements.Responsibilities:Ensure monitoring, and correction of the quality management system according to ISO 13485Act as management representative for the QMSEnsure QMS processes are established, implemented, and maintained.Report to senior management on the QMS performance and where improvements are neededEnsure everyone in the organisation is aware of customer requirements.Promotion of awareness of applicable regulatory requirements related to QMS in the companyRegulatory compliance regarding the EU MDR), and its verification in line with QMSEnsuring conformity of medical devices is checked, in accordance with the QMS before releasePost-market surveillance obligations are complied with in accordance with MDREnsuring the reporting obligations referred to in Articles 87 to 91 of the MDR are fulfilledEnsure updating and maintenance of the Quality manualControl and management of all CAPA activities and execution of internal auditsCoach, train and guide peers and team members - team management and stakeholder management is a key element of the positionEstablish where needed KPIs to track and measure performance of the QMSReview metrics and utilise statistical approach when providing feedback to the businessOversee document control procedures including preparation and review of quality policiesBecome an active part of the site leadership teamAssist & mentor wider teams/departments on local and global manufacturing Medical device standardsQualifications/SkillsIdeally degree educated or similar practical expertise in Quality ManagementQuality Management within a licenced manufacturer, within Medical DevicesInternal/External audit expertise, preferably a certified internal auditor (although not a deal breaker)People ManagementAbility to work on-site at least 4 days a week as this a manufacturer To find out more about Real, please visit



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