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About the Role
Responsible for quality assurance of manufactured and sold products, and for building and maintaining a quality management system in compliance with QMS Ministerial Ordinance and Abbott Quality Policy (AQ).
Responsibilities
- Create and maintain product acceptance inspection and labeling procedures (packaging instructions).
- Store manufacturing record documents.
- Create and manage quality documents (creation, approval management, and storage of procedures/records, etc.).
- Participate in the product launch process and collaborate with necessary departments.
- Configure legal label output and define/approve display items in collaboration with related departments.
- Manage outsourced acceptance inspection operations.
- Manage non-conforming products (input into dedicated system, communication with overseas manufacturers, and data aggregation).
- Review change information from overseas manufacturers and share with related departments.
- Conduct and manage internal and supplier audits.
- Coordinate with related departments (Safety Management Group, Logistics Group) during recalls/revisions.
- Improve business processes.
- Project management experience and active participation in projects (for Sr Specialist).
Requirements
- Completed a specialized course in physics, chemistry, metallurgy, electrical engineering, mechanical engineering, pharmacy, medicine or dentistry, or linguistics at a university, junior college, vocational school, high school, etc., or if the course was other than the above, has three or more years of experience in quality control or post-marketing safety management of medical devices.
- Basic PC skills (Excel, Word, PowerPoint).
- English reading comprehension and communication via email.
Skills
- Quality Assurance
- Quality Management System (QMS)
- Abbott Quality Policy (AQ)
- Product Acceptance Inspection
- Labeling Procedures
- Packaging Instructions
- Document Control
- Product Launch Process
- Legal Labeling
- Outsourced Operations Management
- Non-conforming Product Management
- Change Management
- Internal Audits
- Supplier Audits
- Recall Management
- Process Improvement
- Project Management
- PC Skills (Excel, Word, PowerPoint)
- English Reading Comprehension
- Email Communication
Experience Level
- Senior Specialist
Education Level
- University
- Junior College
- Vocational School
- High School
- Specialized course in physics, chemistry, metallurgy, electrical engineering, mechanical engineering, pharmacy, medicine or dentistry, or linguistics
- Three or more years of experience in quality control or post-marketing safety management of medical devices