工作职责Key Responsibilities:

1. 主导质量体系要求的计划和实施，确保新产品顺利转入生产。/Lead the planning and implementation of quality system requirements to ensure a smooth and compliant transfer of new products into manufacturing.
2. 主导风险管理活动，确保适当的风险控制到位，确保产品和流程安全、可靠和合规。/Lead risk management activities to ensure appropriate risk controls are in place and that products and processes are safe, reliable and compliant.
3. 开发、审核和批准质量体系文件，确保符合内部质量管理体系要求和适用的法规标准./Develop, review and approve quality system documentation to ensure compliance with internal QMS requirements and applicable regulatory standards.
4. 与开发团队合作，确保新产品和制造工艺符合设计规范和法规要求。/Collaborate with Development team to ensure new products and manufacturing processes meet design specifications and regulatory expectations.
5. 与运营团队合作，确保将设计规范有效地传递给制造部门。/Collaborate with Operations teams to ensure effective transfer of design specifications to manufacturing.
6. 协调监管注册所需的现场审核，确保文件、程序和资源准备就绪。/Coordinate onsite audits required for regulatory registration, ensuring readiness of documentation, procedures, and resources.
7. 通过准备提交监管文件所需的高质量文件来支持产品注册工作。/Support product registration efforts by preparing high-quality documentation required for regulatory submissions.
8. 识别并实施质量体系流程的改进，以简化产品转移，同时保持质量和合规性。/Identify and implement improvements to quality system processes to streamline product transfers while maintaining quality and compliance.
9. 在开发和转移生命周期的早期识别和解决质量问题，以防止延迟，降低产品注册和发布时间表的风险。/Identify and resolve quality issues early in the development and transfer lifecycle to prevent delays and reduce risk to product registration and release timelines.
10. 实施和推动供应商和零部件资格认证程序，以确保供应商符合食品和生产要求，包括进行供应商审核和管理必要的纠正措施。/Implement and drive supplier and part qualifications processes to ensure suppliers meet F&P requirements, including conducting supplier audits and managing corrective actions as needed.
11. 提供质量体系程序、监管期望和最优实践方面的指导。/Provide coaching on quality system procedures, regulatory expectations, and best practices.
12. 及时响应并提供支持并对运营质量咨询、调查和问题进行解决。/Support in responding and resolving operational quality inquiries, investigations, and issues.

任职资格Qualifications:

1. 本科或以上学历。/Bachelor’s degree or higher
2. 至少3年在规范的生产和设计环境中从事质量保证或质量体系工作的经验/Minimum 3 years of experience in quality assurance or quality systems within a regulated manufacturing and design environment
3. 具有适用于食品和生产的法规标准的工作知识（例如：NMPA， ISO 13485, FDA QSR）/Working knowledge of regulatory standards that apply to F&P (e.g. NMPA, ISO 13485, FDA QSR)
4. 有新产品引进或产品转移的工作经验/Experience with new product introductions or product transfers
5. 熟悉风险管理工具/Familiarity with risk management tools
6. 较强的分析、解决问题和沟通能力。/Strong analytical, problem-solving, and communication skills.
7. 注重细节，有很强的文档和组织能力/Detail-oriented with strong documentation and organizational skills
8. 具有统计和流程改进工具的工作知识/Working knowledge of statistics and process improvement tools
9. 谈判和影响技巧/Negotiating and influencing skills
10. 有内部和外部审计经验或认证优先考虑/Internal and external auditing experience or certification is a plus
我们提供What we offer:

1. 充满活力和创新的工作环境/Dynamic and innovative work environment/
2. 具备专业的职业成长和发展机会/ Professional growth and development opportunities
3. 有竞争力的薪酬和福利/ Competitive salary and benefits
4. 团队人才济济，携手完成项目/Exciting projects with a talented team