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About the Role
The Head of Quality Assurance Japan sets direction and strategy for the Japan QA team, supporting multiple Business Units including CRM, EP, HF, NM, and SH. This role is responsible for implementing and maintaining an effective Quality Management System compliant with regulatory, quality, business, and global QMS requirements.
Responsibilities
- Budget management and resource allocation
- Goal setting, commitment and performance evaluation of staff
- Competency requirements, training plans, execution and effectiveness evaluation
- Leading continuous improvement activities
- Oversee Quality Management System (QMS) activities and Manufacturing control activities
- Oversee warehouse activities, Quality control and Labeling
- Supervise activities led by the Safety Management Officer
- Supports cross-functional improvement initiatives
- Process improvements for QMS effectiveness and PMD Act compliance
- Follow-up of audit observations/nonconformities
- Participation in new process launches and projects
Requirements
- Degree or specialized coursework in physics, chemistry, metallurgy, electrical engineering, mechanical engineering, pharmacy, medicine, dentistry, linguistics, or equivalent
- At least three years of experience in medical device quality management or post-marketing safety
- Basic PC skills (Excel, Word, PowerPoint)
- English communication skills
- People management experience in a medium-sized or larger organization
- Knowledge of medical device regulatory requirements, ISO 13485 or ISO 9001, or completion of related training
- Experience as auditee during regulatory inspections
- Project management experience
Location
- Japan > Tokyo : Hamarikyu Park Side Place 9F, 17F 5-6-10,Tsukiji,Chuo-ku
Work Type
- Standard
Education Level
- Degree or specialized coursework in physics, chemistry, metallurgy, electrical engineering, mechanical engineering, pharmacy, medicine, dentistry, linguistics, or equivalent
Salary/Compensations
- N/A
About the Company
- JOB FAMILY: Engineering
- DIVISION: EP Electrophysiology