Senior Supplier Quality Expert CATS

Freseniusmedicalcare; Palazzo Pignano; In loco; EUR 65.000 - 90.000; Tempo pieno

Descrizione del lavoro

Fresenius Medical Care is seeking a Senior Supplier Quality Expert CATS at the Palazzo Pignano plant in Italy. This onsite role focuses on leading supplier quality management across the Bloodlines division, assuring supplier compliance, and driving continuous improvement within the supply chain.

You will collaborate with Procurement, Operations, R&D, Regulatory Affairs, and external suppliers to uphold high quality standards and regulatory alignment. Fluent English is required; German is a plus.

Competenze

• Bachelor's degree in engineering or quality discipline is required.
• Experience in supplier quality or supplier management in regulated environments.
• Knowledge of GMP and ISO 9001/13485 standards is essential.

Mansioni

• Lead supplier quality management activities for the Bloodlines division.
• Plan and execute supplier audits, qualification, and development programs.
• Ensure supplier quality compliance with regulatory standards.
• Drive CAPA, change control, and supplier-related process validation.
• Collaborate with Procurement, Operations, R&D, and Regulatory Affairs.

Conoscenze

Fluent English

German (advantage)

GMP knowledge

Quality management

ISO standards

Supplier QA tools

Formazione

Bachelor's degree in Engineering, Biomedical Engineering, Quality Management, or related field

Descrizione del lavoro

Senior Supplier Quality Expert CATS

Location: Palazzo Pignano (CR)

Work Model: Onsite

At Fresenius Medical Care, we are the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver high-quality, innovative products, services, and care across the entire healthcare journey. Guided by our vision-"Creating a future worth living. For patients. Worldwide. Every day."-we work with purpose and compassion, supported by a global team of over 125,000 employees.

Within our Care Enablement segment, we develop and provide life-sustaining medical products, digital health solutions, and therapies that empower clinical teams and improve patient outcomes. Our FME Reignite strategy drives transformation through innovation, efficiency, and sustainable growth.

Our values guide how we work:

• We Care for our patients, each other, and our communities


• We Connect across teams and borders to deliver excellence together


• We Commit to doing things the right way- growing with purpose and leading kidney care with integrity and innovation

Information about plant

Located in northern Italy, our Palazzo Pignano plant serves as a key center for the production and development of dialysis-related medical devices. With more than 550 employees, the plant specializes in manufacturing both peritoneal dialysis (PD) disposables and hemodialysis (HD) bloodline components. It combines large-scale production capabilities with strong R&D and engineering expertise. By utilizing advanced technologies to ensure the highest standards in dialysis product manufacturing, we're not only driving innovation - we're also creating meaningful change for patients worldwide.

Join our passionate team and be part of this global impact!

The Opportunity

As a Senior Supplier Quality Expert CATS , you will play a key role in driving Supplier Quality Management activities in Palazzo Pignano manufacturing site. You will be responsible for ensuring supplier compliance, product quality, and continuous improvement throughout the supply chain, while supporting strategic supplier development and regulatory compliance initiatives. Working closely with Procurement, Operations, R&D, Regulatory Affairs, Supplier Engineering, and external suppliers, you will contribute to maintaining the highest quality standards for our medical device manufacturing operations.

Your Responsibilities

Supplier Quality Management

• Lead Supplier Quality Management activities within the Bloodlines division.


• Implement and maintain Supplier Quality Assurance systems in alignment with global FMC policies and procedures.


• Drive supplier qualification, selection, auditing, and continuous development programs.


• Ensure supplier compliance with quality requirements and regulatory standards.


• Support supplier process validation, risk management, and change management activities.


• Assess and approve supplier-related changes through Change Control processes.

Supplier Audits & Compliance

• Plan and conduct on-site and remote supplier audits in accordance with ISO 13485 and applicable regulatory requirements.


• Monitor supplier performance and quality metrics.


• Ensure material and product quality across the entire supply chain.


• Support site and supplier transfer activities.


• Collaborate with Regulatory Affairs and Quality teams to ensure ongoing compliance.

Quality Systems & Continuous Improvement

• Investigate and manage supplier-related deviations, complaints, and CAPA activities.


• Analyze supplier performance data and develop improvement plans.


• Prepare and present supplier performance reviews and management reports.


• Identify quality risks and implement corrective and preventive actions.


• Promote continuous improvement initiatives and best practices across the supplier network.

Stakeholder Collaboration

• Act as a key quality partner for Procurement, Operations, R&D, Regulatory Affairs, Supplier Engineering, and manufacturing sites.


• Support SOP deployment and training activities across the assigned plants.


• Provide expert guidance on supplier quality topics and quality management processes.


• Collaborate with suppliers, notified bodies, and regulatory agencies when required.

Your Profile

• Bachelor's degree in Engineering, Biomedical Engineering, Quality Management, or a related technical field.


• Several years of experience in Quality Management, preferably in Supplier Quality or Supplier Management.


• Experience in supplier qualification, audits, supplier development, and quality system implementation.


• Strong knowledge of supplier quality tools and methodologies.


• Experience working in a regulated environment, preferably within MedTech, pharmaceutical, or healthcare industries.


• Fluent English; German language skills are considered a strong advantage.

Technical & Professional Skills

• Strong knowledge of GMP requirements and quality management systems.


• Good understanding of ISO 9001, ISO 13485, MDSAP, and applicable regulatory requirements.


• Practical experience with