品質保証シニアスペシャリスト/ QA Sr. Specialist

A multinational medical device manufacturer is looking for a QA Sr. Specialist. The selected candidate will oversee quality assurance operations for medical devices, ensuring compliance with regulatory and QMS standards.

Responsibilities:

• Serve as the Quality Responsible Person for manufacturing and distribution operations
• Decide on product market release based on quality evaluations
• Assess and verify manufacturing and quality control practices of domestic and international partners
• Manage quality change controls and issue necessary quality documentation
• Conduct internal audits and maintain compliance with ISO 13485 and QMS
• Collaborate with cross-functional teams to resolve quality-related issues and drive improvements

Requirements:

• Bachelor’s degree or above
• More than 3 years of experience in QMS management and for Class III or higher medical devices
• Experience in responding to regulatory authorities (interactions with third-party organisations) is ideal
• Prior experience in supplier audits is a plus
• Proven experience in leading projects or teams is preferred
• Understanding of the pharmaceutical and Medical Device Act (PMD Act) and QMS Ordinance
• Business level English (TOEIC 600+) is desired

About the Company:

A multinational medical device manufacturer, this company provides a range of specialty equipment used in critical surgical procedures.

Keywords:

製薬, メディカル, サイエンス, 求人, 外資系

Job Ref: 6E1F9S