Job Description

We are seeking a Quality Manager to oversee safety operations and ensure compliance with Good Vigilance Practice (GVP) requirements in Japan. This role will also handle Quality Management System (QMS) activities, working closely with global teams and local leadership.

Description

* Manage GVP operations as the appointed Safety Controller (Anseki) in Japan
* Establish and maintain effective GVP processes aligned with global post-market surveillance systems
* Serve as subject matter expert for post-market surveillance in Japan
* Drive process improvement initiatives to enhance quality and efficiency
* Handle QMS operations, ensuring compliance with ISO standards and local regulations
* Work with global functions and overseas manufacturers to align on quality standard

Profile

A successful QA Safety Manager should have:

* Bachelor's degree or higher, ideally in a scientific or technical discipline
* Minimum 3 years' experience in post-market surveillance in the Japanese medical device industry
* Strong knowledge of Japanese GVP and QMS regulations (MHLW Ordinance 169 & 135)
* Business-level English and Japanese communication skills
* Proven project management and stakeholder engagement skills
* Ability to handle multiple priorities and solve problems
* Proficiency in Excel and quality complaint handling systems

Job Offer

* Attractive annual salary of 10,000,000-12,000,000 JPY, with potential for adjustment based on experience
* Full benefits package designed to enhance health, security, and work-life balance
* Chance to work in a high-performing, professional environment
* Access to resources for skill enhancement and ongoing professional growth

If you are passionate about quality assurance and safety in the medical device sector, we encourage you to apply and take the next step in your career.

To apply online please click the 'Apply' button below. For a confidential discussion about this role please contact Sobi Tantisakchaichan on +81357337165.

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