Quality Assurance Lead, Soukatsu (Hybrid)

Overview

A global healthcare company is seeking a QA Lead (Soukatsu) to oversee quality assurance activities across product quality, distribution, warehousing, logistics, and commercial operations. The role will take a leading role in maintaining and continuously improving the local Quality Management System, ensuring compliance with Japanese regulatory requirements, and supporting alignment with global quality standards.

Working closely with internal stakeholders, global and regional Quality and Regulatory Affairs teams, customers, and external manufacturing and supply partners, the QA Lead will provide quality expertise, manage critical quality activities, and help drive a strong culture of compliance and continuous improvement in Japan.

Key Responsibilities

• 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

Required Experience

• 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.
  

Preferred Experience

• Experience in QA across both medical devices and pharmaceuticals.
  


• Experience with safety management activities.
  


• Experience supporting PMDA or other regulatory authority inspections.
  


• Experience in distribution, warehouse management, and commercial quality operations.
  


• Experience working within a global or matrix organization.
  


• Experience leading cross-functional quality initiatives or projects.
  

Benefits

Working Hours & Benefits

• 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