Job Description
1. Possess excellent independent judgment and decision-making abilities, and be capable of leading the team to analyze and resolve complex, non-routine quality issues in the production process using testing equipment and professional methods.
具备卓越的独立判断与决策能力,能带领团队运用检测设备及专业方法分析并解决生产过程中的复杂、非常规质量问题。
2. Strong data analysis capabilities, proficient in using quality tools such as the 7 QC Tools, SPC (Statistical Process Control), and FMEA (Failure Mode and Effects Analysis); those proficient in statistical analysis methods are preferred.
具备熟练的数据分析能力,熟练运用 QC 七大工具、SPC(统计过程控制)、FMEA(失效模式与影响分析)等质量工具,精通统计分析方法者尤佳。
3. Familiar with ISO 13485 quality management systems, holding an internal auditor certificate; familiar with relevant regulations such as FDA QSR820 and NMPA (National Medical Products Administration), and those with compliance management experience are preferred.
熟悉 ISO 13485、ISO 9001 质量管理体系,持有内审员证书;熟悉 FDA QSR820、CFDA(国家药品监督管理局)等相关法规,具备合规管理经验者优先。
4. Master ...
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