A global medical technology leader is hiring a Quality Systems Manager to oversee quality operations for designated medical device product lines. This role ensures regulatory compliance, cross-functional coordination, and execution of quality initiatives that impact patient safety, product lifecycle management, and regulatory readiness. You'll lead audits, manage safety processes, and play a critical role in advancing quality culture in a highly respected healthcare organization.
Key Responsibilities
- Lead quality oversight for assigned product categories to ensure compliance with local and international regulations
- Partner with quality leaders across therapeutic areas to align practices and share knowledge
- Coordinate communication and joint activities with quality teams in other group entities
- Approve shipment releases, product changes, safety actions, and CAPAs
- Manage repair/resale notifications and ensure timely resolution
- Support external audits and contribute to regulatory communications as needed
- Review internal procedures and support cross-department quality discussions and escalations
Required Skills and Qualifications
Experience:
- Deep understanding of medical regulations, QA/QC standards, and global compliance frameworks
- Several years of hands-on experience in quality assurance within a medical device or regulated healthcare environment
- Proven involvement in safety actions including field corrections or product withdrawals
Soft Skills:
- Experience leading or mentoring others in a corporate quality function
- Strong communication and coordination skills across complex internal networks
- Analytical and adaptable mindset with sound decision-making ability
- Ability to read and interpret technical English documentation
Language Requirements:
- Japanese: Fluent
- English: Conversational to Business level
Preferred Skills & Qualifications
- Experience with ISO 13485, QMS auditing, and Japan's PMDA requirements
- Background in handling global audits and working with multinational QA teams
- Familiarity with product lifecycle documentation and digital quality tools
About the Company
Our client is a globally respected medical technology company delivering innovative therapeutic solutions across cardiovascular, neurological, surgical, and diabetes care. Operating in over 150 countries, the company focuses on improving patient outcomes through clinical innovation, digital transformation, and healthcare partnership. With a culture built on collaboration, quality, and purpose, it offers its employees opportunities to grow professionally while contributing to meaningful global healthcare impact.
Why You'll Love Working Here
- Join a market-leading medical technology brand with global reach
- Work closely with global and regional leadership on high-visibility projects
- Collaborate across international teams and product divisions
- Be part of a trusted and respected healthcare community
- Enjoy competitive compensation, flex time, and remote work options
Don't Miss Out - Apply Now!
