Key Responsibilities 主要职责:
一、QMS & Document Management: 质量体系与文件管理:
1、Maintain and operate the quality management system relevant to the Making process, ensuring compliance with company and customer requirements.维护和运行生产/Making过程相关的质量管理体系，确保其符合公司及客户要求。
2、Interpret, translate, and maintain customer technical standards and internal quality documents (e.g., standards, specifications).解读、转化并维护客户技术标准及内部质量文件（如标准、规范）。
3、Review internal quality documents, identify Key Control Points (KCPs) and potential risks (Risk Assessment), and write or update Standard Operating Procedures (SOPs) / Work Instructions (WIs).审核内部质量文件，识别关键控制点 (KCPs) 和潜在风险 (Risk Assessment)，编写或更新操作规程 (SOP) / 作业指导书 (WI)。
4、Ensure production compliance during internal and external quality system audits (e.g., ISO 9001, customer audits); support audit preparation and activities.确保生产过程在内部及外部质量体系审核（如 ISO9001、客户审核）中的合规性；支持审核准备及相关活动。
二、Production Quality Control & Improvement: 生产过程质量控制与改进:
5、Responsible for reviewing and confirming Control Plans for Key Quality Characteristics/Parameters, ensuring their adequacy and effectiveness.负责审核和确认关键质量特性/参数 (Key Quality Characteristics/Parameters) 的控制计划 (Control Plan)，确保其充分性和有效性。
6、Proactively identify potential quality risks within the Making process, with a particular focus on risks related to Key Quality Characteristics/Parameters.
主动识别生产/Making过程中的潜在质量风险，尤其关注关键质量特性/参数相关的风险。
7、Assist in establishing and implementing statistical process analysis (e.g., SPC) to monitor key process parameters and product characteristics; utilize data analysis for the continuous improvement of raw material and finished product quality related to the Making process.协助建立并实施过程统计分析（如SPC），以监控关键工艺参数和产品特性；利用数据分析持续改进与Making过程相关的原材料和成品质量。
8、Lead investigations into quality anomalies occurring during the Making process, proficiently applying root cause analysis tools (e.g., 5 Whys, Fishbone/Ishikawa/4M1E, 5W1H) for systematic analysis.主导生产/Making过程中出现的质量异常调查，熟练运用根本原因分析工具（如 5 Whys, 鱼骨图/人机料法环, 5W1H）进行系统性分析。
9、Manage and track the implementation of Corrective and Preventive Actions (CAPA), verifying their effectiveness to ensure closed-loop problem resolution.管理、追踪纠正和预防措施 (CAPA) 的实施，并验证其有效性，确保问题得到闭环解决。
10、Support internal quality audits, and collaborate with relevant departments (e.g., Production, Engineering) to jointly develop and drive the implementation of improvement measures for identified findings or risks, following up to verify effectiveness.支持内部质量审核，并协同相关部门 (如生产、工程部) 针对发现的问题或识别的风险，共同制定并推动实施改进措施，跟进验证改进效果。
11、Responsible for the maintenance and continuous improvement of key QA/QC processes within the Making area.负责关键质量保证/质量控制 (QA/QC) 流程的维护和持续改进。
三、Supporting Activities: 支持性工作:
12、Provide back-up support to the analytical laboratory for necessary testing and analysis as needed.在需要时，为分析实验室提供必要的检测分析支持。
13、Perform other related duties as assigned by management.完成上级主管安排的其他相关工作。
资质和要求：
Qualification & Requirement:
1、Education: Bachelor's degree or above, preferably in Chemistry, Chemical Engineering, Materials Science, Engineering, or a related field.学历: 本科及以上学历，化学、化工、材料、工程或相关专业优先。
2、Experience: 3+ years of experience in quality management within a manufacturing environment. Experience in chemical, FMCG, pharmaceutical, or food industries focusing on production process quality is preferred.经验: 3年以上制造型企业质量管理经验，有化工、日化、制药或食品行业生产过程质量管理经验者优先。
3、Familiarity with ISO 9001 or other relevant quality management systems.
熟悉 ISO9001 或其他相关质量管理体系。
4、Proficiency in common quality tools and methodologies such as SPC, FMEA, Control Plan, 8D, 5 Whys, Fishbone, Risk Assessment, etc.熟练掌握常用的质量工具和方法，如 SPC, FMEA, Control Plan, 8D, 5 Whys, Fishbone, Risk Assessment 等。
5、Ability to review control plans and conduct process risk assessments.具备审核控制计划和进行过程风险评估的能力。
6、Proven ability to lead problem-solving and root cause analysis.具备领导问题解决和根本原因分析的能力。
7、Good documentation writing and reviewing skills.良好的文件编写和审核能力。
8、Basic laboratory operation and analytical skills are a plus.具备基本的实验室操作和分析能力者优先。
9、Excellent cross-functional communication, coordination, and collaboration skills.优秀的跨部门沟通、协调和协作能力。
10、Good teamwork spirit.良好的团队合作精神。
11、Proficient in using MS Office suite.熟练使用办公软件 (MS Office)。
12、Language: Good command of both written and spoken English and Chinese (Mandarin).语言: 良好的中英文读写和口语能力。