QC Manager

Join to apply for the QC Manager role at Fresenius Medical Care 1 week ago Be among the first 25 applicants Join to apply for the QC Manager role at Fresenius Medical Care Get AI-powered advice on this job and more exclusive features. About Us Fresenius Medical Care is the world’s leading provider of dialysis products and services, offering innovative solutions and high-quality treatment concepts. Our mission is to continuously enhance the quality of life for dialysis patients — worldwide and every day. Quality Control Manager Location: Palazzo Pignano (CR), Italy Company: Fresenius Medical Care About Us Fresenius Medical Care is the world’s leading provider of dialysis products and services, offering innovative solutions and high-quality treatment concepts. Our mission is to continuously enhance the quality of life for dialysis patients — worldwide and every day. Our manufacturing plant in Palazzo Pignano specializes in the production of bloodlines and operates 24/7 with a dedicated team of over 550 employees. Within this dynamic and highly regulated environment, our Quality departments play a pivotal role in establishing, maintaining, and continuously improving an effective and efficient Quality Control system within the Technological Laboratory. Their efforts ensure full compliance with product and quality control specifications in line with corporate standards and regulatory requirements applicable to the plant. Key Responsibilities Establishment of a plant training system for Quality Control people. Maintaining a local Document Management System including a document review together with the local document owners in order to maintain the local management system up-to date, correct and effective. Reporting to local management about the management system performance, with focus on the identification of improvement potentials. SME for relevant processes during meeting internal or with external NB. Responsible for semifinished product release and batch record approval. Monitoring and reporting on assigned KPI. Internal Quality Audits Support the QA Manager during internal audits, inspections, and external audits. Monitor the implementation and evaluate the effectiveness of corrective actions resulting from internal audits, corporate audits, regulatory and certification bodies audits, as well as improvement projects. Quality Control Reporting and follow up of the status and the effectiveness of corrections, corrective actions and preventive actions related to product quality and product risks. Maintain the validated state of the corresponding testing methods according to the specification. Ensure the use of calibrated testing equipment. Support internal non conformity and complaint investigation. Support CAPA process. Tools Definition and implementation of supporting tools, e.g. software to support the tasks with regards to the Quality System and internal auditing. Contribution to the definition and implementation of QS relevant projects for QCT. Contribution to the definition and implementation of QS relevant software support for QCT. Your Profile Minimum of 2 years of experience in Quality Control and at least 5 years in a managerial position. Proven leadership and team management skills, with a collaborative and inclusive mindset. Ability to work cross-functionally, manage conflicts with diplomacy, and approach challenges with a proactive and solution-oriented attitude. Excellent interpersonal and communication skills, with the ability to build effective relationships with colleagues, team members, management, and both internal and external stakeholders. Solid knowledge of ISO 13485 and ISO 14971. Experience with validation practices, sterilization processes, and cleanroom environments is considered a plus. Good command of English (intermediate level or higher). Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Quality Assurance, Manufacturing, and Engineering Industries Hospitals and Health Care Referrals increase your chances of interviewing at Fresenius Medical Care by 2x Sign in to set job alerts for “Quality Assurance Manager” roles. Agrate Brianza, Lombardy, Italy 2 weeks ago Test Manager Financial Services - Milano Gestione Reclami Quality Manager Automotive Corporate Quality Manager - Pre Marketing & Safety (Pharma) Quality Assurance Intern - Settore Healthcare We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. J-18808-Ljbffr

Location: palazzo-pignano, IT

Posted Date: 6/16/2025