Cluster Expert (Quality, LMR & EHS)

Job description

At Fresenius Medical Care, we’re dedicated to improving the lives of patients with chronic kidney disease through innovative, high-quality products and treatments. Our vision— “Creating a future worth living. For patients. Worldwide. Every day. ”—guides everything we do. With over 110,000 people working across 3,700 dialysis centers and 39 manufacturing sites worldwide, we provide direct patient care through our Care Delivery network, develop and supply medical products, therapies, digital solutions via Care Enablement, and accelerate transformation through our FME Reignite strategy. Our values drive us: We Care for our patients, each other, and our communities. We Connect across teams and borders to deliver excellence together. And we Commit to doing things the right way, growing with purpose, and leading kidney care with innovation and compassion. As part of this commitment, Systems, Quality & Regulatory (SQR) — a global function within Care Enablement—ensures product quality and safety, regulatory compliance, and market access throughout the entire product lifecycle. The team drives quality across manufacturing and supply chain processes, manages post-market surveillance, and promotes continuous improvement, system harmonization, and sustainability. SQR also oversees Q&R data governance and delivers key product-related business services. Join our passionate team and help shape healthcare worldwide! Goal of function: The LMR Cluster Expert function is responsible to ensure: The implementation, maintenance and continual improvement of the Global Management System (GMS), GMS Basic System and the applicable specific management systems according to global requirements and in compliance with local regulatory and statutory requirements. To act as interface between Global functions, Cluster Lead and local Management with regards to GMS and applicable regulatory requirements. This role is responsible for QMS and EHS for a cluster of countries (Slovenia, Croatia and Bosnia ) within EMEA and ensures consistent, high-quality implementation and execution of QMS and EHS requirements and guidelines across the countries under the respective responsibility. Some of Your responsibilities: Ensuring the adaptation of the applicable global requirements into the local system to achieve best possible results of the practical operations and ensuring regulatory and statutory compliance Supporting responsible functions at local and cluster level in the implementation of the assigned management systems. Ensuring the promotion of awareness of regulatory, statutory and respective stakeholder requirements at local and cluster level. Reporting on the status of the assigned management systems, their performance and opportunities for improvement. Coordinating the local management review and reporting to local management including, the follow-up of decisions and resulting action items, as required. Acting as interface with global HQ functions, local functions and external certification and regulatory bodies within the cluster in scope. Ensuring that additional needed local directives in the respective scope, are established, implemented, maintained and improved. (Implementation includes directives that are additional to the established management system(s) that are required due to regulatory requirements'.: Pharmacovigilance or EHS Regulatory related Directives for the cluster) Ensuring training organization and realization in coordination with local responsible training functions, Ensuring that mandatory e-learning training and requirements are in place in the global Compliance Wire or other E-learning tools, as applicable. (e.g. mandatory training of LMR, implementation of QRIS). Reviewing compliance of the local organization with requirements of the assigned local management systems (e.g. by evaluation of KPIs, by audits) of the countries from the cluster in scope. Coordinating gap analysis check of applicability and process risk assessment before their implementation into the local management system(s) of the cluster, together with local experts (e.g. identification of control measures). Organizing annual directives review together with the process owners, to maintain, update, correct GMS locally for all the countries within the scope of the respective cluster. Coordinating annual global audits including audits by certified bodies, i.e. coordination of audit schedule and plan, organize on-site visits, with the applicable global department. Maintaining system applicable data (e.g. registration of units, change notification to global function/ notified/ certification body). Ensuring that appropriate improvement measures (e.g. corrective action/ preventive action/ CAPA) are performed, as required, Providing consultancy for local process owners on the identification of root-causes and performance of corrective action/CAPA related to identified risk cases, (e.g. product re-calls). Coordinating with applicable global department for activities related to external audits and subsequent identified improvement actions (e.g. notified bodies, authorities). Conducting or coordinating EHS communication (interface to EHS System team in case of tender/customer requests with Global/Product relevance) Coordinating annual declaration of EHS compliance of local operations by responsible local CE management Carrying out regulatory monitoring of local applicable EHS regulations (monitoring, evaluation, registration, communication), Managing EHS related aspects for purchasing Your profile: At least 2 - 5 years of experience in a similar position (for GMS/QMS processes) Bachelor’s degree in life sciences or equivalent educational background Training in relevant internal GMS processes and organisational structures Minimum of 2 years’ experience in the MedTech industry would be a strong asset Minimum 2 years of experience in the implementation and maintenance of management systems (QMS/GMS) Experience in processing documentation and controls Expertise in cross-functional coordination at regional level Experience in internal auditing and or in internal auditing processes Experience in cross-functional coordination at regional level Good knowledge of regulatory and statutory requirements with respect to medical devices (e.g. EU MDR) Good knowledge of applicable quality management system standards (ISO9001, ISO13485) Good knowledge of the applicable environmental management system standard (ISO14001), and/or FME’s related basic requirements as applicable High language proficiency in English (written & oral) Our Offer for you: There is a lot you can discover at Fresenius Medical Care, regardless in which field you are an expert and how much experience you have - all dedicated to your professional journey. Whether in front of or behind the scenes - you are helping to make ever better medicine available to more and more people around the world Individual opportunities for self-determined career planning and professional development A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one A large number of committed people with a wide range of skills, talents and experience The benefits of a successful global corporation with the collegial culture of a medium-sized company