Lead Specialist, Quality Management Systems

Stryker · Tokyo, Japan

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QualityFull-timeCompany career page

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What they're looking for

5+ years medical device QMS operations experience
Understanding of Pharmaceuticals and Medical Devices Act and related regulations
Knowledge of ISO 13485:2016 and QMS regulatory requirements
Problem-solving and logical reasoning abilities
Stakeholder communication and collaboration skills
Japanese and English language proficiency

What you'll be doing

Lead QMS development, maintenance, and continuous improvement aligned with ISO 13485
Manage quality documentation systems including SOP creation and staff training
Plan and execute internal audits with corrective action follow-up
Oversee NC/CAPA processes including root cause analysis and preventive measures
Prepare quality metrics and reports for management review and improvement initiatives

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RoleLantern checkedNeeds clarity

Date posted4 days ago

Last source check1 day ago

Salary listedNeeds clarity

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