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 process
• Create 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 deficiencies
• Execute product complaint investigations related to applicable CMOs
• Design transfer activities linked to change control execution for the related CMO manufacturing processes in support to the Design Ownership team
• Identify and report problems relating to products, processes, and quality systems
• Audit hosting and execute on the CMO related processes as required
• Support 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 reports
• Support 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 discipline
• Mininum 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 industry
• Proficient in German and highly fluent in English, both written and spoken
• Highly 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 23500
• Electronical 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 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

• Ensure manufactured products at the CMO applicable locations (Non-FME sites) meet all required quality control parameters by executing the final product release process
• Create 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 deficiencies
• Execute product complaint investigations related to applicable CMOs
• Design transfer activities linked to change control execution for the related CMO manufacturing processes in support to the Design Ownership team
• Identify and report problems relating to products, processes, and quality systems
• Audit hosting and execute on the CMO related processes as required
• Support 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 reports
• Support planification, execution and communication, during internal and external audit processes applicable for Ober-Erlenbach sit