This position is responsible for leading quality assurance and post-market quality activities for medical devices in Japan. The role is also expected to flexibly support related regulatory, technical, operational, and business activities as needed.
Core Responsibilities
The role ensures compliance across the product lifecycle, while maintaining product quality, business continuity, supply reliability, and customer satisfaction.
This position is responsible for leading quality assurance and post-market quality activities for medical devices in Japan. The role is also expected to flexibly support related regulatory, technical, operational, and business activities as needed.
The role ensures compliance across the product lifecycle, while maintaining product quality, business continuity, supply reliability, and customer satisfaction.
Statutory Appointments
Domestic Quality Assurance Manager
- Manage and supervise manufacturing control and quality control activities to ensure proper execution.
- Provide instructions for corrective actions in the event of nonconformities or quality
- defects, and require maintenance or improvement of product quality.
- Verify the appropriateness of manufacturing processes, records, and the work environment, and request improvements when necessary.
- Reports significant issues related to manufacturing or quality control to the General Marketing Supervisor and proposes necessary actions.
- Assesses regulatory implications of quality-related changes and supports implementation of appropriate regulatory actions.
- Collaborates with global and local stakeholders to ensure compliance with evolving regulatory requirements.
- Manage the operation of the Quality Management System (QMS) and issue instructions to relevant departments.
If necessary, the Domestic Quality Assurance Manager may also serve as the General Marketing Supervisor and/or Sales Office Manager.
Qualifications, experience, know-how and skills
- At least 3 years of experience in quality assurance
- Possesses sufficient knowledge and experience in pharmaceutical regulations, characteristics of medical devices, the entire MAH business process from raw material procurement to product shipment, manufacturing methods and control, quality control operations, and post-marketing safety management, with the ability to comprehensively understand and appropriately assess these areas
Skills Required
- At least 3 years of experience in quality assurance
- Knowledge and experience in pharmaceutical regulations
- Knowledge of medical device characteristics
- Experience with the marketing authorization holder business process from raw material procurement through product shipment
- Knowledge of manufacturing methods and controls
- Experience or knowledge of quality control operations
- Experience or knowledge of post-marketing safety management
- Ability to comprehensively assess quality, regulatory, manufacturing, and post-marketing requirements
Fresenius Medical Care Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Fresenius Medical Care and has not been reviewed or approved by Fresenius Medical Care.
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Leave & Time Off Breadth — PTO is described as ample for 3x12-hour shifts and is complemented by paid caregiver leave, holidays, and sick time. This range of time-off options provides meaningful flexibility for many roles.
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Healthcare Strength — Medical coverage includes 100% preventive care, office-visit copays, prescription coverage, and disability insurance, while dental covers preventive, basic, and major restorative services up to an annual limit. Vision benefits are also available.
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Wellbeing & Lifestyle Benefits — Wellness programs feature the Rally app with fitness rewards, virtual therapy, and an Employee Assistance Program with free counseling. Additional offerings like digital physical therapy and expert medical opinions broaden holistic support.
Fresenius Medical Care Insights
What We Do
Fresenius Medical Care is the world’s leading provider of products and services for individuals with renal diseases. We aim to create a future worth living for chronically and critically ill patients – worldwide and every day. Thanks to our decades of experience in dialysis, our innovative research and our value-based care approach, we can help them to enjoy the very best quality of life. Our portfolio encompasses a comprehensive range of high-quality health care products and services as well as various dialysis treatment options for both in-center and home dialysis that are individually tailored to our patients’ needs.
