Quality Assurance Manager ~ Medical Device
Posted Updated
Description
This role is responsible for leading and managing quality processes for medical devices, with a primary focus on the Japanese market.
The position offers the opportunity to collaborate closely with cross-functional teams across the company.
- Develop, review, and maintain documentation for the device quality management system.
- Manage and assess suppliers in Japan and internationally, resolving quality-related issues.
- Lead or support internal and external audits, including preparation, execution, and follow-up.
- Coordinate with global teams on quality activities such as complaints, CAPA, non conformance, change control, and supplier evaluations.
- Stay current with regulations and standards applicable to medical device quality systems.
Requirements
- Bachelor’s degree in science, engineering, or a related field.
- Minimum of 3 years’ experience in the medical device industry
- Hands-on experience with quality systems, CAPA, audits, and regulatory inspections.
- Strong knowledge of Japan’s PMD Act, ISO 13485, and MHLW MO 169.
- Familiarity with FDA 21 CFR Part 820 and ISO 14971 is a plus.
- Proficient in Japanese; strong English communication skills preferred for international collaboration.