Design Quality Assurance Expert

Introduction section

At Fresenius Medical Care, we are the world's leading provider of products and services for individuals with renal diseases. 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 112,000 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:

At our Changshu plant in China, we manufacture life-sustaining products that support dialysis patients around the world. Our portfolio includes dialyzers, bloodline sets, dialysis solutions, hemodialysis machines, and key medical components. Using advanced technologies such as injection molding, extrusion, and automated assembly, our teams help ensure the highest standards of quality and reliability. Join us and become part of a global team committed to creating a future worth living for patients worldwide.

Design Quality Assurance Expert

Role&Responsibilities:

• Ensure design quality compliance of medical device design and development activities throughout the product lifecycle. Act as the Design Quality representative within cross-functional project teams, providing oversight of design controls, design transfer and design change activities in accordance with applicable regulations, standards, and internal procedures.
• Ensure compliance of design and development activities with regulatory, quality, and design control requirements.
• Represent Design Quality in product development, design transfer and design change projects.
• Review and approve design control deliverables, Design History File (DHF) documentation, and project milestones.
• Support preparation of documentation required for regulatory submissions and technical files.
• Participate in Design Reviews, Phase Exit Reviews, and compliance assessments.
• Provide training and guidance on design control and quality requirements.
• Review and approve Design & Development-related NCs, CAPAs, and change controls.
• Conduct audits and compliance checks to ensure adherence to the Quality Management System (QMS).
• Support design transfer activities and collaboration between R&D, Regulatory Affairs, and Manufacturing.

Job Requirements

• 10 years’ experience in medical device is desirable
• Advanced knowledge of medical device regulations (NMPA regulation, MDD 93/42/EEC, MDR 745/2017, MDSAP etc.)
• Advanced knowledge of applicable quality management and of risk management standards (e. g. ISO13485, ISO14971, ICH Q10, EU GMP, FDA 21 CDR §820.250, etc.)
• Knowledge of internal and external processes and structures and of the corporate Quality Management requirements
• Knowledge of CAPA methodology
• Basic Knowledge in statistical methods
• Good in stakeholder management and communication
• Understands balance between business needs and product quality & regulatory requirements
• Trusted quality partner in cross-functional project meetings
• Cross functional leader managing on site design quality aspects on local level and well connected to global level