Head of Manufacturing Quality – Heart & Lung (m/f/d)

At Fresenius Medical Care, the world’s leading provider of products and services for individuals with chronic kidney disease, we are committed to improving lives through innovative, high-quality products and treatment concepts. Our goal is to enhance the quality of life for our dialysis patients—worldwide, every day. With more than 120,000 employees globally, we focus on both Care Delivery and Care Enablement—the latter driving innovation in medical products and therapies.

Since 2016, Xenios AG has been part of Fresenius Medical Care and specializes in life-saving technologies for extracorporeal heart and lung support systems. With over 230 employees and two production sites in Germany, Xenios AG develops state-of-the-art medical devices designed to support patients in intensive care. Our mission is to deliver groundbreaking solutions that combine advanced technology with exceptional clinical expertise.

Ready to shape the future of quality in medical technology?

We are looking for an experienced and driven individual to take on the role of Head of Manufacturing Quality – Heart & Lung (m/f/d) at our Stolberg site. In this pivotal leadership position, you will oversee and further develop our Quality Management System (QMS), ensuring compliance with international regulatory requirements and the highest product quality standards.

Your Tasks

• Lead and manage the Network Quality Management System in full compliance with:

  • Local and/or corporate GMS QMS policies and procedures

  • Relevant standards such as EN ISO 13485

  • Regulatory requirements of EMEA countries (e.g. Annex II of the European Medical Device Directive 93/42/EEC)

  • Regulatory requirements of non-EMEA markets where products are distributed (e.g. CMDCAS for Canada, 21 CFR 820 for the US, CQC for China)

• Act as a strategic advisor to local senior management regarding the effectiveness and efficiency of the local management system, identifying non-conformities and areas for improvement

• Report to local senior management on management system performance, with a strong focus on improvement opportunities

• Collaborate closely with the Plant General Manager and leadership team to align product quality with overall business objectives

• Serve as the Local Management System Representative (LMR), representing the IMS function at the site level

• Recommend and support the implementation of process improvements, including changes to manufacturing and process control requirements as well as related documentation

• Set strategic direction for product quality initiatives and continuous process improvements

• Provide quality guidance and support to Operations and Engineering teams, especially in matters of compliance, validation, and facility modifications

• Ensure effective follow-up and evaluation of corrective actions from internal, corporate, and external audits, as well as improvement initiatives

• Coordinate and prepare for external audits, including scheduling (in collaboration with the notified body/GMS), developing audit plans, and managing communication of relevant data to GMS

• Establish and maintain consistent quality control and compliance programs across the site

• Report on and track the status and effectiveness of corrective and preventive actions related to product quality and associated risks

• Ensure a high level of product quality and regulatory compliance throughout the Heart & Lung network

• Oversee timely and effective complaint investigations within the designated complaint investigation unit(s)

Your Profile

• University degree in a scientific, engineering, or medical field (e.g. Life Sciences, Medical Engineering, Engineering)

• Minimum of 10 years of experience in Quality Management, ideally within the medical device or similarly regulated industry

• At least 2–5 years of leadership experience in a senior quality role

• In-depth knowledge of relevant standards and regulations (e.g. ISO 13485, ISO 14971, FDA QSR, MDR)

• Familiarity with notified bodies and regulatory agency interactions

• Strong leadership, decision-making, and communication skills

• Fluent in English and German (written and spoken);

• Proficient in IT systems and tools (e.g. SAP, MS Office, Trackwise)

• Willingness to travel domestically and internationally

What We Offer

• A high-impact leadership role with responsibility for quality and compliance of life-saving medical products

• A dynamic, international environment

• Opportunities to shape processes and drive continuous improvement initiatives

• Ongoing professional development in a global organization committed to innovation and patient safety

Be part of something meaningful — join us and help shape the future of healthcare.

We look forward to receiving your application!