Global Quality Manager

Job Title

Global Quality Manager

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.

Position Overview

• Department: Quality Center
• Location: Singapore or USA (with frequent business travel to the other location as required)
• Reporting Line: Quality Director
• Management Scope: Full responsibility for quality management across both Singapore and the U.S.

Position Description

We are looking for a Global Quality Manager to be based in either our Singapore or US 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. You will also partner closely with R&D teams to ensure robust design control, design history file (DHF) management, and design change processes throughout the product development lifecycle.

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.
• Proven experience in R&D quality systems, including design control, DHF (Design History File), design verification & validation, and design change management. Candidates with only supplier quality or manufacturing quality background without R&D quality experience will not be considered.
• 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.

Why Join Us

• Globally competitive compensation package — salary open to negotiation based on experience and performance.
• Fast-growing and promising platform — Play a key role in building quality management systems in key international markets, with internal growth opportunities.
• Global exposure — Work in an international environment covering multiple markets, with frequent business travel expanding your global perspective.
• Dynamic and innovative culture — A resilient, open-minded, and results-driven team that values personal growth and contribution.
• Comprehensive benefits — Competitive insurance and other flexible perks.

Location & Travel

This role can be based in either Singapore or the United States, depending on the candidate's preference and business needs. Regardless of the base location, frequent business travel to the other country is required to ensure seamless quality management across both regions.

How to Apply

If you are ready to take on a challenging and rewarding global quality leadership role in a fast-growing MedTech company, we'd love to hear from you. Please submit your CV or send it directly to [Confidential Information] or [HIDDEN TEXT].

职位名称

全球质量经理

关于公司

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

• 所属部门: 质量中心
• 工作地点: 新加坡或美国(需根据业务需要频繁前往另一国家出差)
• 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

职位介绍

该职位将设于新加坡或美国办公室(根据候选人意愿及业务需要确定)。您将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。您还需要与研发团队紧密合作,确保产品开发全生命周期内设计控制、设计历史文件(DHF)及设计变更流程的稳健合规。

任职要求

• 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。
• 具备研发质量体系的实战经验,包括设计控制、设计历史文件(DHF)、设计验证与确认、设计变更管理等。仅具备供应商质量或生产制造质量背景、缺乏研发质量经验者不予考虑。
• 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。

加入祥生,你将获得

• 极具竞争力的薪酬体系 — 薪资开放,根据个人能力与经验面议。
• 快速发展的国际化平台 — 参与搭建全球质量体系,职业发展空间广阔。
• 全球视野与出差机会 — 常驻新加坡或美国,并频繁往返两地,深度接触国际业务。
• 充满活力的团队氛围 — 开放、务实、以结果为导向的团队文化。
• 全面的福利保障 — 完善的保险及其他弹性福利。

关于地点与出差的说明

该职位可根据候选人意愿及业务需要,常驻新加坡或美国。无论base在何处,均需频繁前往另一国家出差,以确保两地质量管理的有效衔接与落地。

如何申请

如果您希望在快速发展的医疗科技企业中担任富有挑战性的全球质量岗位,欢迎与我们联系。请通过领英投递简历,或直接发送至 [HIDDEN TEXT]或 [HIDDEN TEXT]

。