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).