Join a leading American-headquartered women's healthcare company as a QA Safety Specialist, where you'll play a critical role in maintaining and improving quality management systems (QMS) and ensuring post-market safety for innovative medical devices. This is an opportunity to work in a global environment with hybrid flexibility, contributing to the advancement of healthcare through science-driven diagnostics.
Key Responsibilities
- Keep the Quality Management System (QMS) updated and compliant with internal guidelines and global standards
- Support global and domestic post-market surveillance (PMS) activities to ensure product safety and timely reporting
- Assist with internal and external audits to ensure adherence to regulations like ISO 13485
- Manage controlled QMS documentation including SOPs, manuals, and procedures
- Investigate product issues such as complaints and non-conformances, and determine appropriate corrective actions or reporting
- Provide regulatory and quality advice during the introduction of new medical devices and in-vitro diagnostics
Required Skills and Qualifications
- Experience: Minimum 3 years in post-market safety for medical devices or IVDs
- Familiarity with Japan's Pharmaceutical and Medical Device Law and GVP guidelines
Language Requirements:
- Japanese: Native fluency
- English: Business-level proficiency
Soft Skills:
- Strong problem-solving, logical thinking, effective time management, and communication skills
Preferred Skills & Qualifications
- Experience with QMS implementation and knowledge of Ordinance No.169 and ISO 13485
- Familiarity with managing external contractors or PMS vendors
- Pharmacist license or internal auditor certification is a plus
- Experience communicating with regulatory authorities and knowledge of IVDs or installation-controlled devices
About the Company
Our client is a global leader in women's healthcare, focused on improving lives through science and innovation. With strong expertise in diagnostics and in-vitro diagnostics (IVD), the company develops breakthrough solutions for disease detection and health management. Their mission-driven culture, hybrid work policy, and commitment to quality make them a top destination for life sciences professionals.
Why You'll Love Working Here
- Contribute to meaningful healthcare innovation that improves patient outcomes
- Hybrid work model - up to three days of remote work weekly
- Career growth in a collaborative, science-driven, and international environment
- Convenient Tokyo location - less than 5 minutes from the station
- Comprehensive benefits including paid leave, flex time, transportation allowance, and social insurance
Don't Miss Out - Apply Now!
