[의료기기/품질관리] RA/QA Manager

An RA/QA Manager position is now available at a multinational medical device manufacturer. The selected candidate will oversee the quality management system's development and efficacy. This role is based in Seoul.

Responsibilities:

• Facilitate site activities to meet regulatory goals, requirements, and submissions
• Manage the design review processes
• Analyse and assess industry standards for quality and regulatory requirement
• Deliver feedback on project initiatives and performances
• Act as a representative on inspections, audits, and investigations
• Give comments on possible issues and challenges

Requirements:

• Bachelor’s degree or equivalent in engineering or quality management
• More than 6 years of medical devices or life sciences experience (electro-mechanical device organisation is a plus)
• Prior project management experience
• Understanding of CGMP/ISO standards, R&D, quality, engineering, and manufacturing
• Knowledge of MS Office suite
• Fluent level Korean; proficient in written and verbal English

About the Company:

Based in the United States, this international medical device company specialises in the development of innovative endovascular robotic systems.

Keywords:

엔지니어링, 제조, 의료기기, 의료, 품질보증, 규제, 국제

1962150/001