Goal of function: This function provides key support to the Manufacturing Quality operations at our Ober-Erlenbach site, by monitoring, implementing, executing, and coordinating the activities and requirements related to the Production Responsibility over the applicable Disinfectant Contract Manufacturing Organizations (CMOs).

Your Responsibilities:

Ensure manufactured products at the CMO applicable locations (Non-FME sites) meet all required quality control parameters by executing the final product release processCreate and/or approve quality documentation as per internal and external requirements (e.g. validation protocols, quality agreements, quality plans, CMO files)Ownership and execution of NCCAPA records related to applicable CMO location deficienciesExecute product complaint investigations related to applicable CMOsDesign transfer activities linked to change control execution for the related CMO manufacturing processes in support to the Design Ownership teamIdentify and report problems relating to products, processes, and quality systemsAudit hosting and execute on the CMO related processes as requiredSupport in quality operations processes at Ober-Erlenbach site as required (complaint investigations, batch release, supplier management, document management, change control)Monitor and analyze KPIs and creating reportsSupport planification, execution and communication, during internal and external audit processes applicable for Ober-Erlenbach site

Your Profile:

Graduate University degree (BA) in mathematics, science, engineering, or related technical disciplineMininum of 3 years practical experience in Quality Management System for Non Active Medical Devices. (Audits, Document Management, NCCAPA, Validation, Supplier Management, Change Control, Risk Management)Minimum 2 – 3 years experience in working in the MedTech or the Pharma industryProficient in German and highly fluent in English, both written and spokenHighly responsible, with strong communication, negotiation skills, and a proactive mindset; effective in independent roles and international, cross-cultural environments.Good understanding and sound knowledge of ISO 13485, ISO 90001, ISO 23500Electronical management system (SAP, Trackwise, LMS, etc.)

Our Offer for you:

There is a lot you can discover at Fresenius Medical Care, because we have a lot to offer. No matter on

in which field you are an expert (m/f/d) and how much experience you have - for your professional career.

A future with meaning:

Whether in front of or behind the scenes - you are helping to make ever better medicine available to more and more people around the worldIndividual opportunities for self-determined career planning and professional developmentA corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest oneA large number of committed people with a wide range of skills, talents and experienceThe benefits of a successful global corporation with the collegial culture of a medium-sized company