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 영문 이력서 및 경력 기술서 지원 선호
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