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Sr Mgr, Quality at embecta - ApplyBlast

Sr Mgr, Quality

embecta

3 months ago

3.5 on Glassdoor

Tokyo, Japan

Onsite

Full Time

Senior

0 applicants

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About this role

This role leads the Japan Quality Management System, overseeing the complete product lifecycle from design to obsolescence for embecta's diabetes care solutions. The position ensures full regulatory compliance with Japan MHLW/PMDA requirements, manages post-market surveillance, and drives continuous improvement initiatives within the local quality team. Key duties include serving as the MAH General Controller, leading audits, and mentoring associates to build strong technical and leadership capabilities.

Responsibilities

Provide overall leadership of the Japan Quality Management System
Ensure compliance with Japan MHLW/PMDA regulations and global policies
Lead transition and integration activities for product portfolio changes
Oversee complaint intake, triage, and post-market surveillance processes
Mentor and develop the Japan Quality team members

Skills

Qualifications

Bachelor's degree in Life Sciences, Engineering, or related fieldExperience with ISO 13485 and ISO 14971 standardsKnowledge of Japan MHLW/PMDA regulations