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About the Role
Participate in developing and maintaining the organization to quality standards exceeding customer expectations and coordinate activities with internal and external customers. Execute departmental activities for adherence to PMD Act requirements, corporate policies, and relevant quality system procedures. Represent the company against applicable Japanese regulatory bodies as required.
Responsibilities
- Ensure all activities are performed in compliance with quality system requirements.
- Support the development and maintenance of necessary procedures in compliance with PMD Act and corporate policies to perform Quality Assurance activities.
- Participate in the development of the Quality Assurance organization, demonstrate effective leadership, and monitor compliance with PMD Act and relevant company procedures.
- Provide recommendations to management regarding safety and/or quality measurements, such as product removal due to significant patient injury by product malfunction.
- Provide management with information on significant product quality issues and monitoring results of Quality Assurance activities.
- Implement or manage the development, maintenance, or improvement of key quality processes, including sub-processes such as Management Responsibility, Purchasing Controls, Change Management & Document Control, Product Approval, Production & Process Controls, Improvement (Corrective and Preventive Action), and Post Market Support.
- Support the implementation of impact goals for other departments within Quality, Safety, and Compliance (QSC).
- Participate in OACA-related activities and support the implementation of OACA processes in Japan.
Requirements
- Completed a specialized course in physics, chemistry, biology, engineering, informatics, metallurgy, electricity, mechanics, pharmacy, medicine, or dentistry at a university.
- Engaged in quality assurance work for 3 years or more.
- Proficient in Word, Excel, and PowerPoint.
Skills
- Communication
- Logical thinking
- Presentation
- Negotiation
- Problem-solving skills
- Good knowledge of PMD Act and QMS.
- Business-level English skills preferred.
- Good knowledge of clinical usage for Vascular products preferred.
- Good knowledge of Quality System (e.g., Qualified Lead Auditor related ISO13485) preferred.
- Good knowledge of product design and manufacturing process preferred.
- Good knowledge of logistics and supply chains of medical devices preferred.
- Good knowledge of business style of medical devices (consignment sales) preferred.
- Qualified Lead Auditor related ISO13485 preferred.
Location
- Japan > Tokyo : Mita South Tower, Minato-ku
Work Type
- Standard
Experience Level
- 3 years or more in quality assurance or related work.
- Project lead or group leader level management experience preferred.
Education Level
- University degree in physics, chemistry, biology, engineering, informatics, metallurgy, electricity, mechanics, pharmacy, medicine, or dentistry.
- 4-year university degree in medical, pharmacology, scientific, or engineering-related fields preferred.
About the Company
- The company operates in the Vascular business division.