你是否热衷于在医疗器械行业中发挥真正的影响力？你是否喜欢挑战并不断学习？你是否在寻找一个能听取你想法、支持你成长的工作环境？Are you passionate about making a real impact in the medical device industry? Are you someone who thrives on challenges and continuous learning? Are you looking for a place where your ideas are heard, and your growth is supported?
如果这些问题让你心动，这可能就是你一直在寻找的机会。If these questions excite you, this could be the opportunity you’ve been looking for.
费雪派克医疗在用于呼吸和急性护理和治疗阻塞性睡眠呼吸暂停的医疗设备方面居世界领先地位。过去一年中，我们在120多个国家治疗了1400万患者，极大地改变了人们的生活。Fisher & Paykel Healthcare is a world leader in the delivery of medical devices for the use in respiratory and acute care and in the treatment of obstructive sleep apnea. We have treated 14 million patients in more than 120 countries in the past year. We make a difference in people's lives.
我们正在寻找一位有经验的研发质量工程师加入我们位于广州的团队。这个职位在支持我们制造先进医疗器械产品的过程中起着关键作用。We are currently seeking an experienced Design Quality Engineer to join our expanding team in Guangzhou. This is a key role supporting our ability to manufacture and deliver cutting-edge medical devices that improves patients’ lives.
工作内容What You’ll Do:
主导质量体系要求的规划和实施，确保新产品顺利且合规地转入量产阶段。
Lead the planning and implementation of quality system requirements to ensure a smooth and compliant transfer of new products into manufacturing.
主导风险管理活动，确保适当的风险控制措施已到位，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.
制定、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.
与研发团队合作，确保新产品和制造流程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.
与运营团队合作，确保将设计规范有效地转移至生产端。
Collaborate with Operations teams to ensure effective transfer of design specifications to manufacturing.
协调进行法规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.
通过准备高质量的文件资料，支持产品注册所需的法规提交工作。
Support product registration efforts by preparing high-quality documentation required for regulatory submissions.
识别并实施质量体系流程的改进，以简化产品转移流程，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.
在产品开发与转移周期的早期阶段识别和解决质量问题，防止延误并降低对产品注册和上市时间表的风险。
Identify and resolve quality issues early in the development and transfer lifecycle to prevent delays and reduce risk to product registration and release timelines.
推动并执行供应商和零部件资格认证流程，以确保供应商符合公司要求，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 company requirements, including conducting supplier audits and managing corrective actions as needed.
提供关于质量体系程序、法规期望和最优实践方面的指导。
Provide coaching on quality system procedures, regulatory expectations, and best practices.
支持处理与解决运营质量相关的资询，调查和问题。
Support in responding and resolving operational quality inquiries, investigations, and issues.

我们希望你具备What We’re Looking For:
本科或以上学历。
Bachelor’s degree or higher
3年以上在受监管的制造与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
熟悉相关法规标准（例如：NMPA， ISO 13485, FDA QSR）
Working knowledge of regulatory standards (e.g. NMPA, ISO 13485, FDA QSR)
有新产品导入或产品转移的工作经验
Experience with new product introductions or product transfers
熟悉风险管理工具
Familiarity with risk management tools
较强的分析能力、问题解决能力和沟通技巧
Strong analytical, problem-solving, and communication skills.
注重细节，具备良好的文件记录与组织管理能力
Detail-oriented with strong documentation and organizational skills
具有统计和流程改进工具的工作知识
Working knowledge of statistics and process improvement tools
谈判和影响他人的能力
Negotiating and influencing skills
有内部和外部审计经验或认证者优先考虑
Internal and external auditing experience or certification is a plus
具备六西格玛绿带或黑带认证者优先考虑
Six Sigma Green or Black Belt certification is a plus
加入我们的理由Why Join Us?
作为回报，我们将为你提供一个机会，加入一个充满活力与奉献精神的团队，成为一家致力于员工与客户的企业文化的一部分。我们始终专注于改善患者的生活，并致力于为员工提供高质量的工作与生活体验。
In return, we will offer you an opportunity to work as part of a dedicated and energetic team at a company with a fantastic culture of commitment to our employees and customers. We relentlessly focus on improving patients' lives and strive to provide a high quality of life for our employees.
如果你准备好迎接挑战、实现成长、并创造影响，欢迎加入我们！请立即和我们分享你的简历。
If you’re ready to grow, lead, and make a difference — we’d love to hear from you. Please apply today with your CV in English.