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About the Role
Getinge's mission is to deliver life-saving technology to more people. To deliver value to customers and ultimately save lives, we need teamwork, forward-thinking, and game-changing colleagues. Are you looking for an inspiring career? It's here.
Responsibilities
- Oversee manufacturing and sales quality operations for Getinge Group Japan Co., Ltd.
- Manage product quality (QC part), including maintaining product inspections with third-party manufacturers and reporting defects to overseas manufacturers.
- Handle regulatory compliance (QMS part), managing and responding to QMS inspections (audits) by regulatory bodies like the Pharmaceuticals and Medical Devices Agency (PMDA) and certification bodies.
- Conduct quality assurance (QA) operations, responding to domestic regulatory requirements under the direction of domestic product quality managers and safety managers.
- Collaborate with domestic registered manufacturers to conduct and maintain inspections.
- Report defects and share quality information with overseas manufacturers.
- Coordinate with service, sales, and other departments to address quality improvements, including handling inspection non-conformities.
- Maintain all procedures managed by the company in accordance with Global QMS.
- Respond to QMS conformity investigations and maintain certificates of compliance.
- Maintain foreign manufacturer registration.
- Support management review activities.
- Manage documents and records.
- Manage suppliers.
- Manage CAPA (Corrective and Preventive Actions).
- Support external audits.
- Support internal audits.
- Support supplier audits.
- Support corporate audits.
- Manage and support core systems such as SAP.
Requirements
- Ability to build smooth cooperative relationships with administrative agencies (MHLW, PMDA, TMG, etc.).
- Ability to build good relationships with relevant departments (especially Logistics (SCM), Service, Marketing, Sales), improve processes, and proactively work towards improving overall company quality.
- Ability to build and maintain a positive mindset without being aggressive towards others.
- English communication skills (ability to communicate via email, etc.).
- Approximately 3 years of QA/QC experience in a Type 1 medical device manufacturing and sales business.
- ISO 13485 auditor qualification (preferred).
- Supplier audit experience (preferred).
- Practical experience with SAP (preferred).
- Expertise and experience in Japanese quality regulatory requirements and QA/QC.
- 3+ years of QMS experience in the medical industry (experience with Class II/III conformity investigations).
- Understanding of Japanese regulatory requirements and ISO 13485 standards.
- Excellent communication and presentation skills, including presentations and training.
- Ability to build good interpersonal relationships within the department and with other departments.
- Proficiency in work and the ability to consistently engage in tasks and complete them within deadlines.
- Practical knowledge of Word, Excel, PowerPoint, etc.
- Ability to maintain an organized workspace.
Skills
- English communication
- QA/QC
- ISO13485 auditing
- Supplier auditing
- SAP
- Japanese quality regulations
- QMS
- Medical device quality
- Communication
- Presentation
- Interpersonal skills
- Time management
- Microsoft Office (Word, Excel, PowerPoint)
Location
- Japan
Work Type
- Full flexible system
- Full-time
Experience Level
- 3+ years
Salary/Compensations
- ¥5,500,000 - ¥7,800,000 (determined based on experience and skills, includes bonus)
- Monthly salary: ¥370,000 - ¥591,000 (Base salary: ¥296,000 - ¥472,800 + fixed overtime allowance for 30 hours: ¥74,000 - ¥118,200)
- Bonus: Once a year (March)
- Salary revision: Once a year (January)
Benefits
- Social insurance complete
- Defined contribution pension plan (company type DC)
- Benefit One (cafeteria plan)
- Paid leave (granted according to month of entry)
- Sick leave
- Childcare/Family care leave system
- Childcare leave
About the Company
- Getinge's mission is to deliver life-saving technology to more people.
- Getinge provides products and solutions that improve clinical outcomes and optimize workflows for hospitals and life science facilities.
- Their areas of expertise include intensive care, cardiovascular surgery, operating rooms, sterile reprocessing, and life sciences.
- Getinge has over 12,000 employees worldwide, and its products and solutions are used in more than 135 countries.