Ensure smooth execution of quality assurance duties, maintain regulatory compliance, and drive continuous improvements within the organization.
Roles/Responsibilities
- Ensure operations comply with the Pharmaceuticals and Medical Devices Act and the QMS Ministerial Ordinance.
- Manage reception, processing of quality information, and provide customer support.
- Maintain compliance with ISO standards.
- Encourage foreign manufacturers to maintain and improve product quality.
- Lead and coordinate product recall or repair efforts, including communication with authorities.
- Oversee pharmaceutical affairs, public relations （PMDA, Tokyo Metropolitan Government）, and manage foreign manufacturer registrations and QMS inspections.
Required skills
- Strong knowledge of the Pharmaceutical and Medical Device Act.
- 3＋ years of experience in quality assurance for medical devices.
- Practical experience in manufacturing management and quality assurance is a plus.
Preferred skills
- Proven experience leading teams or projects.
- Science background preferred, with the ability to understand product mechanisms and communicate effectively with logical thinkers.
- Proficient in English communication （verbal and email） and capable of smooth collaboration across departments and with external stakeholders.
About our client
This company is a global leader in providing innovative medical device products and services for surgery, neurotechnology, spine, and orthopaedics. Renowned for their dedication to patient and healthcare outcomes, this company impacts over 150 million people across the globe every year. Through collaborations with customers across the globe, the company continues to drive advancements in medical technology. Their employees enjoy a flexible and rewarding work setting that encourages growth and internal mobility, leading to very high employee satisfaction and retention.
