Job Description
<Job Responsibilities> - Manage and maintain the QMS in compliance with ISO and regulatory requirements. - Oversee quality inspections for incoming materials, in-process production, and finished medical devices. - Lead internal audits, handle non-conformities, and implement CAPA actions. - Monitor quality performance and drive continuous improvement initiatives. - Supervise QA/QC staff and coordinate quality activities with production and engineering teams. - Review and approve quality documentation and support regulatory compliance.. - Other tasks as assigned.
Job Requirement
<Necessary Skill / Experience > ・Min. Bachelor's degree in Engineering ・Min. Conversational English proficiency ・Min. 3 years as Quality (QA/QC) Senior Staff in Medical Equipment Manufacture company ・Knowledge of related ISO, GMP, and quality tools (CAPA, FMEA, SPC) ・Excellent analytical, leadership, and communication skills