Position Name职位

Quality Manager

质量经理

Department部门

Refer to myHR

JD Revise date 修订日期

01.Jun.2026

Primary Purpose

职位设置目的

· Support the company and its affiliates in Suzhou, to provides the direction and leadership to the Quality Organization of Phillips-Medisize Suzhou.

协助本公司在苏州关联公司, 领导Phillips-Medisize苏州工厂质量组织。

Duties& Responsibilities

工作职责

· Holds the responsibility and oversight for product and facility regulatory filings and submissions, reporting activity, consulting, and regulatory agency communications

承担产品及工厂法规监管文件归档，提交，汇报，咨询及与监管机构定期交流的责任

· Serves as a key customer and regulatory interface to assist in business development

充当关键客户和监管接口，协助业务发展

· Defines, communicates, and gains cross functional and cross-site support for the quality system and compliance strategy to mitigate product and compliance risk

负责定义，沟通，和获取对质量体系和 合规战略的跨功能和跨工厂的支持，以减轻产品合规风险

· Establishes the site Quality KPIs and for RA and compliance metrics

建立工厂质量指标及合规性衡量

· Conduct management review and ensure data analysis is conducted, reported and reviewed.

开展管理评审，且确保进行、报告和评审数据分析。

· As a representative of management, establishes, implements and maintains a quality management system, reports on the operation of the quality management system and the need for improvement, and provides employees with an awareness of the need to meet statutory, regulatory and customer requirements.

作为管理者代表，建立、实施并保持质量管理体系，报告质量管理体系的运行情况和改进需求，提供员工满足法规、规章和顾客要求的意识

· Organize internal medical device quality management training to improve the quality management ability of the staff.

组织工厂内部医疗器械质量管理培训工作，提高员工的质量管理能力

· Provides direction and leadership to the Quality group including people management as follows:

领导质量小组，为其提供方向，包括以下人员管理：

§ Talent acquisition

人才招募

§ Talent development

人才发展

§ Performance management

绩效管理

§ Employee communication, ensuring team is aligned with and accomplishing goals/objectives; administrative processing; and, maintaining trust and confidentiality while fostering a team environment

员工沟通，确保与团队成员目标的一致性，并完成目标；日常行政事务处理；在培养团队合作环境时，保持互相信任及保密性

· Forecasts headcount and resource needs based on priorities

基于优先顺序预测人力和资源需求

· Drives and delivers global and regional quality initiatives in manufacturing site

推动 全球和区域的质量倡议活动至工厂端

· Leads the quality system management, risk management, product quality assurance throughout the whole product lifecycle

领导整个产品生命周期内的质量体系管理，风险管理及产品质量保障

· Provides quality leadership of adverse event investigations and issues related to customer complaints

领导不良事件及客户投诉的调查

· Production release for Incretin Pen and Incretin Pen II

肠促胰素笔和肠促胰素笔Ⅱ产品放行

· Partners with others to drive costs out of the business and lower operating expenses, drives the continual improvement/innovation in quality team

与其他人合作，从业务中降低成本，降低运营成本，推动质量团队的持续改进创新

· Actively participates in key quality initiatives such as the Global Quality Council; Regional Councils; and subject matter expertise forums

积极参与全球质量委员会，区域委员会及其他主题研讨会

· Follow EHS related laws, regulations and company's EHS related management regulations, timely report potential risk, and propose safety improvement suggestions; For management position, be responsible for EHS management of the department/team.

遵守环境和职业健康安全相关法律法规，遵守公司环境和职业健康安全相关管理规定，及时上报身边安全隐患，并提出安全改进建议；若为管理岗位，需负责本部门、团队的环境和职业健康安全管理。

· Other duties as assigned by Supervisors

其它被主管分配的任务

Scope范围

Location地点：Suzhou 苏州

Reports to汇报对象

Refer to myHR

Supervises管理对象

Quality Engineers; Quality Supervisors and other roles in quality department

质量工程师，质量主管及其他质量部岗位

Contacts沟通与联络

Internal：

内部

­ Global Quality leadership Team

全球质量领导团队

­ Regional plant managers and operations team

区域工厂经理及运营团队

­ Global BDM Team

全球业务发展团队

­ Project Management Team

项目管理团队

­ Site/regional Quality Team

工厂区域质量团队

External：

外部

­ Customers, suppliers, agencies, Notified Bodies, and other business relations

客户、供应商、政府机关、公告机构及其他业务关系方

Function Demands

岗位要求

Education学历

Required必需：

Minimum of a Bachelor’s degree with medical device relevant or technical title of intermediate or above

医疗器械相关专业大学本科以上学历或中级以上技术职称

Preferred优先：

MBA, PhD工商管理硕士，博士

Skills & Abilities技能

Required必需：

· Open minded, embrace challenge and transformation

思想开放，勇于接受挑战和变革

· A strategic and tactical person with the ability to build positive relationships at all levels.Strong technical and problem-solving skills required

具有在各层级建立积极关系的战略战术能力，及较强的技术和问题解决能力

· Strong written, verbal, organizational, and interpersonal communication skills

较强的书写，口头表达，组织，及人际沟通能力

· Project management skills

项目管理能力

· Ability to work in a fast-paced work environment that is matrixed globally

能够在全球矩阵化的快节奏环境中工作

Preferred优先：None

Experience工作经验

Required必需：

· Should have direct expert knowledge in medical device RA product submission lifecycle activities应具备医疗器械产品生命周期活动内的法规递交的直接专业知识

· Minimum 10 years’ experience in Quality/Compliance environment, 5 years as leader in Quality

至少10年以上的质量合规环境工作经验，担任质量领导5年

· Minimum 5 years of proficient experience with the following regulatory/notified body requirements:

至少精通以下法规及公告机构要求5年以上

§ FDA CFR Part 11, part 820; Part 210 and 211;

§ ISO13485:2016.

§ NMPA Regulations

§ EU Medical Device Regulations is a plus

· Significant experience in an overall cGMP / GXP operating environment

在整体cGMP / GXP 运营环境中拥有丰富的经验

Preferred优先：None