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About the Role
Participate in developing and maintaining the organization to exceed customer expectations in quality standards and coordinate activities with internal and external customers. Execute departmental activities for adherence to PMD Act requirements, AV and Abbott Corporate policies, and relevant AVJ quality system procedures. Support business in Japan through departmental activities, such as regulatory reporting and new product introductions.
Responsibilities
- Ensures that all activities are performed in compliance with quality system requirements.
- Support developing and maintaining the necessary procedures in compliance with PMD Act and AV and Abbott Corporate policies to perform Quality Assurance activities.
- Participate in developing the Quality Assurance organization, demonstrate effective leadership of Quality Assurance activities, and monitor compliance with PMD Act and relevant company procedures.
- Provide recommendations to Line manager regarding safety and/or quality measurement, such as product removal due to significant patient injury by product malfunction.
- Provide information of significant product quality issues and results of monitoring Quality Assurance activities to Line manager.
- Implement or manage to develop, maintain, or improve 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 implementation of impact goals for another department of 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.
- Proficiency in Word, Excel, and PowerPoint.
Skills
- Communication
- Logical thinking
- Presentation
- Negotiation
- Problem-solving skills
- Good knowledge of PMD Act and QMS.
- Inspire Others
- Drive Innovation
- Take Initiative
- Deliver Results
- Building relationship
Location
- Japan
Work Type
- Full-time
Experience Level
- 3 years or more in quality assurance
- 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 Vascular division operates within Abbott, adhering to AV and Abbott Corporate policies.