Join a global medical device manufacturer as a Senior QMS Specialist, taking ownership of Japan's Quality Management System (QMS).
This role focuses on ISO13485 compliance, audit management, and regulatory alignment, ensuring adherence to both Japanese and international quality standards. You will work closely with global teams and regulatory authorities, playing a key role in maintaining and improving quality systems in a fast-growing, innovation-driven organization.
Key Responsibilities
- Maintain and improve the Quality Management System (QMS) in line with ISO13485 standards.
- Manage quality documentation, records, and quality manuals.
- Plan and execute internal audits and ensure compliance readiness.
- Handle external audits and regulatory inspections (PMDA, certification bodies).
- Manage CAPA processes and address audit findings effectively.
- Ensure compliance with MHLW regulations and QMS Ordinance in Japan.
- Collaborate with global teams and overseas manufacturers.
- Analyze QMS data and provide reports and insights for continuous improvement.
Required Skills and Qualifications
Experience:
- Experience in Quality Assurance (QA) within the medical device industry, especially QMS.
- Hands-on experience with document control, audits, and CAPA processes.
- Experience handling internal audits and regulatory authority inspections.
Soft Skills:
- Strong attention to detail and ability to manage compliance-driven processes.
- Proactive mindset with the ability to drive continuous improvement initiatives.
- Strong collaboration skills when working with cross-functional and global teams.
Language Requirements:
- Japanese: Native level
- English: Intermediate level (reading and writing)
Preferred Skills & Qualifications
- Experience in Regulatory Affairs (RA)
- Business-level English proficiency
- Experience with medical devices such as implants or disposable products
About the Company
Our client is a global medical device company with strong growth in surgical and rehabilitation fields. With annual revenue of approximately $2.1 billion, the company is expanding rapidly, particularly in surgical technologies. Their product portfolio includes shoulder and hip implants, with future expansion into knee-related solutions.
The company emphasizes a culture of continuous improvement, teamwork, speed, and ownership, offering a dynamic environment for professionals to grow while collaborating globally.
Why You'll Love Working Here
- Join a fast-growing global medical device company in an expansion phase
- Work on cutting-edge technologies including robotics, navigation, and AI
- Strong global collaboration with opportunities to use and develop English skills
- Clear career progression opportunities in a scaling organization
- Flexible working style with remote work, minimal overtime, and flex-time
Don't Miss Out - Apply Now!
