Join a leading global healthcare technology company as a Quality Assurance Specialist, ensuring the safety and compliance of medical devices in Japan. This role involves regulatory oversight, risk management, and cross-border collaboration, requiring bilingual communication to work effectively with global teams. You will play a critical part in protecting patients by driving quality systems, inspections, and compliance initiatives.
Key Responsibilities
- Develop and implement quality assurance plans to ensure products meet regulatory requirements.
- Identify and report quality risks to management, recommending corrective actions.
- Collaborate with international teams to resolve product-related issues.
- Draft, update, and enforce company policies in line with Japanese regulations.
- Communicate with suppliers to manage compliance of externally manufactured products.
- Prepare documentation and manage audits and inspections by regulatory authorities.
- Maintain and update official records and submissions for government compliance.
Required Skills and Qualifications
Education:
Experience:
Knowledge:
Language Requirements:
- Japanese: Native level.
- English: Business-level proficiency.
Preferred Skills & Qualifications
- Experience at a manufacturing site or possession of a pharmacist license.
- Strong knowledge of quality system standards such as QMS, GVP, and ISO.
- Familiarity with process improvement methodologies such as Six Sigma.
- Strong problem-solving, project management, and statistical analysis skills.
About the Company
Our client is a global American healthcare technology company that develops and supplies essential tools for hospitals, clinics, and laboratories. Its portfolio includes syringes, infusion devices, laboratory testing equipment, and surgical instruments. In Japan, the company operates from Tokyo and Fukushima, serving as a critical supplier of high-quality medical products to healthcare providers nationwide.
Why You'll Love Working Here
- Opportunity to contribute to patient safety through quality and compliance.
- Work with global teams using both Japanese and English.
- Strong career development in the medical device and pharmaceutical sector.
- Competitive salary and comprehensive benefits package.
- Flexible working style with flextime and generous leave policies.
Don't Miss Out - Apply Now!
