Global MedTech Leader | Major Business Transformation | High‑Impact QA Leadership Role
Our client is a globally recognized leader in advanced patient monitoring technologies, widely used in operating rooms and intensive care units worldwide.
Their portfolio includes:
High‑ and low‑invasive hemodynamic monitoring systems
Blood pressure and oxygenation sensors
Next‑generation monitoring platforms with cutting‑edge software
The company is currently driving a large‑scale business transition project, and strengthening the Japan Quality Assurance organization is a key strategic priority.
Role Overview:
As the Quality Assurance Manager for Japan, you will oversee all QA activities for the advanced patient monitoring business.
You will ensure product quality and safety, maintain and improve the QMS, manage product licenses, and strengthen collaboration with global manufacturing sites.
You will lead a team of 4 QA Specialists, with a strong focus on project leadership and cross‑functional coordination rather than routine management.
Key Responsibilities:
Ensure compliant operation and maintenance of the Japan QMS
Assess and manage quality/safety information from overseas manufacturing sites
Conduct internal audits and maintain product standard documentation
Lead overseas manufacturing site registrations and support QMS conformity assessments
Manage product license transitions and ensure regulatory continuity
Collaborate with global R&D, Supply Chain, RA, and Commercial teams
Participate in major internal projects, including ERP/system upgrades
Why This Role Is Attractive:
Contribute directly to QA structure development during a major organizational transition
Work in a clinically impactful domain affecting critical care and surgery
Strong global collaboration and exposure
Role opens due to internal promotion — clear growth pathway
Innovative, learning‑oriented corporate culture
Required Qualifications:
5+ years of experience in QA or RA within medical devices or related manufacturing/distribution
Experience with Class II–III medical devices
Experience in license management, QMS operations, quality evaluation, and regulatory projects
Business‑level English & native‑level Japanese
Preferred Qualifications:
Experience with overseas manufacturing site registration
Experience supporting QMS conformity assessments
Market access/reimbursement knowledge
Branding or organizational transition project experience
Calm, structured, and logical communication style
Ideal Candidate Profile:
Highly autonomous and able to self‑drive
Strong prioritization and task‑management skills
Comfortable working with Marketing, Sales, and government authorities
Compensation & Benefits:
Competitive annual salary (based on experience)
Full transportation reimbursement
Location
Akasaka, Minato‑ku, Tokyo
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