Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Summary:概况

This section focuses on the main purpose of the job.

职位的主要目的。

1.Responsible for the development and validation of material standards, testing methods, and process control methods for active medical devices.

负责有源医疗器械物料标准、检测方法以及过程控制方法的开发和验证。

2.Supervise operations to comply with requirements of GMP & ISO.

监督生产运作符合GMP和SOP的要求.。

3.Responsible for endorsing process and product quality, efficacy. And safety through the routine assessment of plant operations and finished products. Responsible for ensuring adherence to the regulatory and procedural requirements that govern those operations and products.

负责过程和产品的质量、功效,通过日常的审核评估活动,保证过程的安全性;确保生产操作和产品符合法规和规程的要求。

4.On-line GMP, ISO and SOP audit to make sure the production process comply with the requirement.

负责生产区域的质量保证审核(包括GMP、ISO和SOP等)。

5.Final product  inspection to make sure the finish goods’ quality compliance.

最终产品的检查以保证产品质量符合规定。

6.Coordinate the exception in process to assure a effective   quality system.

协调生产过程中的异常情况以确保质量体系的有效性。

7. Coordinate the change/validation and online improvement.

协调生产过程中的变更/验证以及生产线的改进。

Essential Duties and Responsibilities:基本义务和职责

This section contains a list of eight primary responsible roles.  The incumbent will perform other duties assigned.

该部分包含了8个主要的责任角色，任职者还须承担一些其它指定的工作。

1.Establish and maintain material standards for active medical device products, and be responsible for the development and validation of relevant testing methods for active medical devices.

建立和维护有源医疗器械产品物料标准，负责有源医疗器械相关检测方法的开发和验证。

2. Supervise operations to comply with requirements of GMP & ISO.

监督生产运作符合GMP和SOP的要求。

3. Set up limit sample and validated product criteria (include sample plan & sample size).

制定在线产品缺陷标准和验证过程的产品接受标准(包括取样计划和取样量) 。

4. Monitor the control of in-process and validation process to make sure the effectiveness.

监督生产过程的监控和验证的过程以确保其有效性。

5. Responsible for the control of exception handling and non-conformance product to make sure the effectiveness and continuous improvement of in-process.

负责在线的异常处理和不合格品的控制,确保其有效性和持续改善。

6. Responsible for training & qualification management of on-line inspector.

负责在线检查员培训和资格管理。

7. Ensure and work in compliance with all EHS aspects.

确保工作符合环保、健康和安全的方针政策。

8. Sr quality material engineer assist to organize and perform the routine operations of the QE Supervisor / Sr. QE Supervisor / QE Manager.

高级质量物料工程师协助组织并实施质量工程主管/质量工程高级主管/质量工程经理的例行工作。

Qualification:资格

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

该职位要取得成功，个人应能令人满意地完成各项基本义务。具备所列的知识、技能及要求具备的能力。对能力稍逊者可以适当调整，要求能完成基本的职责。

1.Able to work and communicate well with other departments' personnel.               具有团队精神和良好的沟通能力。

2.Good command of English speaking and writing.

良好的英语能力。

3.Be familiar with hardware/software principles such as circuit principles and the fundamentals of embedded systems.

Understand relevant tests such as fluid passage and electrical safety test.

熟悉电路原理、嵌入式系统基础等硬件/软件原理。了解流体通路、电气安全等相关测试。

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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