Quality Assurance Lead

Morunda | Pharmaceutical | Medical Device Recruiting | Japan (JPAC) Asia (APAC)

QA Lead overseeing quality assurance activities for a global healthcare company in Japan. Ensuring compliance with Japanese regulations and supporting alignment with global quality standards.

Posted 7/25/2026full-timeTokyo • 🇯🇵 JapanSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Management Systems (QMS) within the medical device industry, ensuring compliance with Japanese regulations and leading critical quality processes such as CAPA and audit management. Strong collaboration with internal and external stakeholders to drive continuous improvement and risk management.

Highest-signal resume keywords

Quality Management System (QMS) ExpertiseJapanese Regulatory ComplianceCAPA ManagementAudit Response ExperienceMedical Device Industry Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

ISO 13485Good Manufacturing Practice (GMP)PMD Act KnowledgeNon Conformance ManagementComplaint HandlingInternal AuditsSelf-InspectionsCorrective and Preventive Actions (CAPA)Quality Risk ManagementQuality Process Improvement

Soft Skills

CollaborationCommunicationLeadershipTraining and DevelopmentProblem Solving

Industry Keywords

Medical Device IndustryQuality Assurance (QA)Regulatory Inspection ReadinessLogistics Quality ActivitiesSupplier Quality Management

About the role

Key responsibilities & impact

Lead day-to-day QA activities and support the effective operation, maintenance, and continuous improvement of the local QMS.
Ensure compliance with Japanese regulations, including the PMD Act and applicable quality standards.
Oversee quality activities related to logistics, warehousing, transportation, and commercial operations.
Lead and support critical quality processes, including CAPA, non conformance management, complaint handling, audits, and regulatory inspection readiness.
Plan and conduct internal audits and self-inspections, and support responses to external audits and regulatory inspections.
Partner with contract manufacturers and suppliers to investigate quality issues, manage risks, and implement appropriate corrective and preventive actions.
Provide quality expertise and guidance to Sales, Operations, Service, and other internal stakeholders.
Support quality-related training and promote a culture of quality, accountability, and continuous improvement.
Identify opportunities to improve QMS effectiveness, reduce quality risks, and streamline processes.
Collaborate with global and regional QA/RA teams to align quality standards, share best practices, and support international projects.
Act as a key quality point of contact for Japan, supporting appropriate escalation and risk-based decision-making.

Requirements

What you’ll need

Bachelor's degree or higher in Science, Engineering, or a related field.
5+ years of QA experience within the medical device industry.
Strong experience operating and maintaining a regulated QMS, such as ISO 13485, GMP, or GQP.
Solid knowledge of Japanese regulatory requirements, including the PMD Act.
Experience with CAPA, non conformance/deviation management, complaint handling, and audit responses.
Experience working with contract manufacturers, suppliers, or external partners on quality issues and investigations.
Business-level English communication skills.

Benefits

Comp & perks

Working hours: 9:00–18:00, with a 1-hour lunch break
Flexible working hours with no core time
Hybrid working available, with approximately 2 days per week remote
Weekends, national holidays, and New Year holidays off