Quality Assurance Specialist

Title: Quality Assurance Specialist

Introduction about us:

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 visionCreating a future worth living. For patients. Worldwide. Every work with purpose and compassion supported by a global team of over 125000 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 Quality System and Quality Assurance (QS/QA) department:

QS/QA is part of Fresenius Medical Care Japan and operates within the Buzen Plant organization where we manufacture peritoneal dialysis solutions and hemodialysis filters. Although the team is based at the Buzen site QS/QA also oversees the quality and regulatory compliance of fiber products manufactured at the Inukai Plant which specializes in fiber production under an ISO13485compliant Quality Management System.

The team ensures that products from both Buzen and Inukai meet the highest standards of quality safety and regulatory compliance throughout the entire product lifecycle. We drive excellence in manufacturing maintain robust document control and data governance oversee supplier and internal audit programs and support regulatory addition QS/QA provides essential qualityrelated business services across global operations and promotes continuous improvement to safeguard product quality and patient safety.

Summary about role:

As a Quality Assurance Specialist you are responsible for ensuring GMP- and ISO13485-compliant quality management and document control across manufacturing sites. The role oversees key QMS processes such as change control deviations CAPA internal audits and data integrity initiatives. It supports regulatory inspections manages supplier quality programs maintains document management systems and prepares or reviews GMP/QMS documentation including batch records and quality records. Additional responsibilities include raw material COA collection SAP data entry visual inspection of packaging materials and cross-site collaboration to ensure consistent quality operations.

Your Responsibilities:

1. Quality Assurance and Document Control based on GMP&QMS(ISO13485) at Buzen Plant

• Execute and support GMP/ISO13485based Quality Management System activities (change control deviations NC/CAPA internal audits).
• Lead Data Integrity (DI) programs including compliance monitoring improvement planning and staff training.
• Support regulatory authority audits and manage assigned followup tasks.
• Perform Supplier Quality Management (SQM): supplier registration change management audit program planning/monitoring and KPI reporting.
• Create revise and manage GMP/QMS documents.
• Maintain the QDOK document management system and provide user training/support.
• Prepare batch records and manage quality records and validation documentation.
• Handle COA collection for raw materials and support incoming material operations.
• Enter raw material and finished product data into SAP.
• Conduct visual inspections of packaging materials.
• Perform other assigned quality assurance tasks as needed.
• Communicate and collaborate effectively with stakeholders across departments and sites to ensure smooth execution of QA and document control activities.

2. Quality Assurance and Document Control based on QMS(ISO13485) at Inukai Plant

• Execute and support Quality Management System activities related to QMS (e.g. change control deviation handling NC/CAPA and internal audit)
• Support regulatory authority audit and handle assigned tasks
• Perform supplier quality management (SQM) activities including supplier registration and change management planning and monitoring supplier audit programs and managing / reporting KPI program
• Create and revise QMS documents
• Maintaining of document management system (QDOK System) and education and support for end users
• Management for Quality Records and Validation Reports
• Perform other quality assurance related tasks as assigned

3. Others

• Communicate and collaborate with stakeholders in a good and appropriate manner as a team in same department/same site/other sites in order to execute works listed above

Your Profile:

• Capable of communicating in Japanese at a Native level.
• Bachelors degree holder with solid proficiency in Microsoft Word and Excel.
• Good understanding of pharmaceutical GMP and medical device QMS (ISO13485).
• Practical knowledge and experience in quality assurance and document control within GMP/QMS environments.
• Capable of communicating in English at a businessbasic level.

Our Offer for you:

There is a lot you can discover at Fresenius Medical Care regardless in which field you are an expert and how much experience you have - all dedicated to your professional journey.

• Operate and maintain GMP/ISO13485based Quality Management Systems including change control deviations nonconformances CAPA and internal audits.
• Lead data integrity activities manage GMP/QMS documentation and maintain the QDOK document control system.
• Support regulatory inspections and ensure audit readiness across both plants.
• Oversee supplier quality through qualification change management supplier audits and KPI monitoring.
• Manage batch records quality records validation documentation and sitespecific quality operations such as COA handling SAP entry and packaging inspections.
• Collaborate effectively with crossfunctional teams at both Buzen and Inukai plants to maintain consistent and compliant quality operations.
• Fulfill granted authorities as Document Control Responsible Internal Auditor and Supplier Auditor contributing directly to the robustness of the quality system.