Join a leading global medical device manufacturer as a Quality Assurance Senior Specialist, ensuring QMS compliance, regulatory adherence, and quality control for innovative healthcare solutions. This role involves global communication, supplier audits, and regulatory coordination, offering high visibility across regional and global teams.
Key Responsibilities
- Ensure QMS Compliance: Establish and revise procedures while maintaining Quality Management System (QMS) standards.
- Manufacturing & Quality Control Evaluation: Approve market release and assess foreign manufacturers' regulatory compliance.
- Quality Improvement & Product Recalls: Lead quality initiatives, complaint handling, and regulatory coordination for product recalls.
- Regulatory Compliance & Licensing: Submit license applications, manage QMS inspections, and oversee investigational device quality.
- Supplier Audits & eQMS Management: Conduct local and global supplier audits and support eQMS as a local administrator.
Required Skills and Qualifications
- Experience:
- Strong interpersonal skills for internal and external stakeholder collaboration.
- Expertise in QMS regulations, particularly in pharmaceutical or medical device industries.
- Proven experience in QA compliance, ISO13485, MDSAP, and PMDA inspections.
- Technical Skills:
- Proficiency in Excel, Word, and PowerPoint for reporting and presentations.
- Language Proficiency:
- Japanese: Fluent (for regulatory coordination and stakeholder communication).
- English: Business level (preferred for global reporting and collaboration).
Preferred Skills & Qualifications
- Experience in foreign-affiliated companies with strong global communication skills.
- Familiarity with international regulatory standards and medical device compliance.
About the Company
Our client is a renowned global medical device manufacturer, transforming the healthcare industry for over 50 years with cutting-edge solutions. The company has a strong presence in Japan, with 180+ employees in Tokyo, and has built successful partnerships with local manufacturers. Due to strong product demand and upcoming launches, they are expanding their QA team in Tokyo.
Why You'll Love Working Here
- Join a stable, experienced QMS team in a leading medical device company.
- Work in an international environment with exposure to regional and global teams.
- Opportunities for career growth in a rapidly expanding industry.
- Competitive salary and strong benefits package.
Don't Miss Out - Apply Now!
