＜Position Title＞ Senior Quality Systems Manager (DIAB @ Tokyo)

＜Working Location＞ Shinagawa HQ

＜About OU＞

The Diabetes Operating Unit focuses on improving the lives of those within the global diabetes community. As a business, we strive to empower people with diabetes to live life on their terms by delivering innovation that truly matters and providing support in the ways they need it. We’re committed to meeting people with diabetes where they are on their journey, always with an aim to make their lives easier. Our portfolio of innovative solutions are designed to provide customers greater freedom and better health, helping them achieve better glucose control, while spending less time managing their disease.  

This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.   

＜Main Responsibilities＞

Responsibilities may include the following and other duties may be assigned. 

• Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines. 

• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance. 

• Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations. 

• Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits. 

• Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external. 

• Co-ordinates legal requests in support of government investigations or litigations. 

• Ensures the quality assurance programs and policies are maintained and modified regularly. 

• Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally. 

＜Must Haves＞

Job Experience  

• Minimum 7 years of relevant experience 

• 5+ years of managerial experience 

• Specific experience leading or participating in external audits, including MDSAP audits and ISO 13485 audits 

• Strong experience for Marketing Authorization Holder – MAH role in Japan 

• Specific experience leading CAPA Programs and/or owning CAPAs 

• Specific experience with improvement and maintenance of Quality Management Systems (5 years) 

Skill / Knowledge 

• Strong knowledge of Japan regulations for medical devices 

• Expert knowledge of Quality Management Systems requirements 

• Japanese native language skills and English business-level proficiency 

Competency 

• Strong leadership skills 

• Strong organizational skills 

• Strong communication skills 

• Strong people management skills 

Education 

• Bachelor Degree (Any faculty or department is acceptable.) 

＜Nice to Haves＞  

Job Experience  

• Expert experience interacting with the Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) 

• Expert experience for Marketing Authorization Holder – MAH role in Japan 

Skill / Knowledge 

• Expert knowledge of Japan regulations for medical devices 

＜Working Style＞

• Hybrid, 3 days needs to be at Shinagawa HQ 

Benefits 

At Medtronic, we believe that the success of the company and the growth of our employees go hand in hand. We offer comprehensive benefits and compensation programs designed to enhance the financial, physical, and mental well-being of each employee. 

• Up to 360,000 yen per year in childcare subsidies 

• Six weeks of leave for family members who require nursing care or for adoption 

• Babysitter and nursery school matching services 

• Career development, including mentor programs and e-learning 

• Internal career network to support women's advancement 

• Employee stock purchase program　 etc. 

Others 

＜Allowances＞ 

• Commuting allowance, overtime allowance, holiday work allowance, etc. 

＜Holidays＞ 

• Saturdays, Sundays, public holidays, etc. 

＜Vacation＞ 

• Annual paid leave, sick leave, menstrual leave, maternity leave, etc. 

＜Working Hours＞ 

• 9:00 a.m. to 5:30 p.m.