Global Quality Manager

职位介绍 (Position Description)

We are looking for a Global Quality Manager to be based in our Singapore office. This role oversees the Quality Management System (QMS) across Singapore and the U.S., ensuring compliance with ISO 13485, FDA QSR, EU MDR, MDSAP, and other applicable global regulations.

You will lead the end-to-end quality process, drive CAPA management and continuous improvement, manage supplier quality, coordinate both internal and external audits, and work closely with HQ on quality system upgrades and strategic initiatives.

该职位将设于新加坡办公室,全面管理新加坡与美国的质量管理体系(QMS),确保符合ISO 13485、FDA QSR、欧盟MDR、MDSAP等相关法规标准。您将主导端到端的质量流程管理,推动CAPA管理和持续改进,管理供应商质量,协调内外部审计,并与总部协同推进质量系统升级与策略制定。

关于地点与出差的说明(A Note on Location & Travel)

This role is based in Singapore but will require frequent business travel to the United States as needed to ensure seamless quality management across both regions.

该职位常驻新加坡,需根据业务需要频繁赴美国出差,以确保两地质量管理的有效衔接与落地。

任职要求(Qualifications)

. Bachelor's degree or above in Engineering, Life Sciences, or a related field.

. 5-8+ years of quality management experience in the medical device industry. Experience with

ultrasound, active medical devices, or high-complexity MedTech is highly preferred.

. Strong hands-on experience with ISO 13485, FDA 21 CFR Part 820, EU MDR, and MDSAP.

. Lead Auditor experience preferred familiarity with ISO 14971 and statistical quality control is a plus.

. Excellent leadership, analytical, problem-solving, and cross-functional communication skills.

. Bilingual proficiency in Chinese and English as working languages, with resilience and an entrepreneurial mindset.

. 工程、生命科学或相关专业本科及以上学历。

. 5-8年以上医疗器械行业质量管理经验,有超声设备或有源医疗器械经验者优先。

. 熟悉ISO 13485、FDA 21 CFR Part 820、欧盟MDR及MDSAP等法规要求。

. 具备体系审核组长经验者优先,熟悉ISO 14971及统计质量控制方法更佳。

. 优秀的领导能力、分析能力和跨部门沟通能力。

. 中英文双语可作为工作语言,具备抗压能力和创业心态。

关于公司(About Us)

Chison Medical (Stock Code: 688358), founded in 1996, is a leading Chinese ultrasound manufacturer with a strong global presence. As a pioneer in the overseas market among domestic brands, we are driven by deep globalization and full digitalization. Our products are exported to over 100 countries and regions worldwide. By 2025, all our product series have passed the EU MDR certification, fully aligning with international standards. We maintain a

global network of R&D, registration, marketing, and local services, with subsidiaries in the U.S., Germany, and Singapore, and local deployments in Brazil, Mexico, Egypt, India, and beyond.

With a strong focus on R&D, Chison has built a core AI-driven competency and remains a dynamic, innovative player in global medical imaging.

祥生医疗(股票代码:688358),成立于1996年,是国内领先、海外市场表现卓越的中国超声品牌。我们坚持 深度全球化 与 全面数字化 双轮驱动,产品远销全球100多个国家和地区。2025年全系列产品已通过欧盟MDR认证,接轨国际标准。目前公司在美国、德国、新加坡设有子公司,并在巴西、墨西哥、埃及、印度等地进行本地化布局,构建了覆盖全球的研发、注册、营销及本地服务体系。依托持续的研发投入与强大的AI技术能力,祥生医疗正以专业与创新服务于全球医疗市场。

职位基本信息(Position Overview)

. Department: Quality Center

. Location: Singapore(with frequent business travel to the United States as required)

. Reporting Line: Quality Director

. Management Scope: Full responsibility for quality management across Singapore and the U.S.

. 所属部门: 质量中心

. 工作地点: 新加坡(需按业务需要频繁赴美出差)

. 汇报对象: 质量总监

. 管理职责: 全面负责新加坡及美国质量管理