Quality Assurance Specialist

Job Title: Quality Assurance Specialist

Location: Tokyo, Japan

About Us: Our client is a global biotechnology MNC, committed to advancing healthcare through innovative medical devices. Our mission is to improve patient outcomes and enhance the quality of life. Join our team and contribute to the development of cutting-edge medical technologies.

Job Description: We are seeking a meticulous and experienced Quality Assurance Specialist to join our team in Tokyo. The ideal candidate will have a keen eye for detail, strong analytical skills, and a passion for ensuring the highest quality standards in our medical devices.

Responsibilities:

• Develop and implement quality assurance policies and procedures specific to medical devices.
• Conduct regular audits and inspections to ensure compliance with industry standards and regulatory requirements (e.g., ISO 13485, FDA).
• Identify and resolve quality issues in collaboration with cross-functional teams, including R&D, manufacturing, and regulatory affairs.
• Monitor and report on quality performance metrics.
• Train and mentor staff on quality assurance best practices and regulatory compliance.
• Stay updated with the latest industry trends, regulations, and advancements in medical device technology.

Requirements:

• Bachelor's degree in Quality Assurance, Biomedical Engineering, or a related field.
• Minimum of 3 years of experience in quality assurance within the medical device industry.
• Strong knowledge of quality assurance methodologies, tools, and regulatory requirements.
• Excellent analytical and problem-solving skills.
• Proficiency in Japanese and English (both written and spoken).
• Ability to work independently and as part of a team.
• Detail-oriented with a commitment to excellence.