CQA Manager

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.

Be the point of contact as quality partner for business unit (BU) to understand and anticipate BU’s quality needs and risks,and be accountable for quality activities of the BU (including but not limited to tough complaint case,regulatory inquiries.)/ 作为业务部门(BU)的质量合作伙伴，了解和预测业务部门的质量需求和风险，对业务部门的质量活动负责(包括但不限于棘手的投诉案件、监管调查)。 Co-ordinate Quality internal resource to support new product launch，including local BD product

协调质量部门内部的资源，支持各业务部门的新产品上市，包括在本地BD的产品

Lead post market survillance activities with BU,i.e.Field actions, important complaint etc./与业务部门相关的后市场监测，包括召回，严重的投诉处理等。 Monitor quality complaints trend and quality accidents , and the report shall have the opinions. 监控产品质量投诉趋势和质量事故的调查、处理和报告。 Communicates with manufacturing plant for significant quality issues identified during compliant or other quality activities and provides recommended process improvement to management/就投诉或者其他活动中发现的重大质量问题与生产工厂进行沟通，并向管理层提供工艺改进建议。 Communication with BU for product quality management.与对应的业务部门沟通产品质量管理。 Responsible for coordinating the recall management of medical devices . 负责协调医疗器械的召回管理 Responsible for PRER review and submission. 负责审核产品的定期风险评估报告等。 Lead oversea inspection 海外检查的协调沟通 Authority sampling and testing support 国内各类抽检的技术支持 Quality improvement project support 支持国内及总部质量改进项目

Qualifications/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. / 想成功地完成这项工作，任职人员必须能够圆满地完成每一项基本职责。列出所需的知识、技能和/或能力。

  N/A:  Intern or Co-op

1. Experience in Drug Quality Management in multinational company; /具有跨国公司药品质量管理经验

2. Expertise in GMP/GSP/ISO standards /熟悉GMP/GSP/ISO标准

3. Strong teamwork spirits; /强烈的团队合作精神

4. Excellent communication skills in both written and verbal English. /良好的书面和口头英语沟通能力，有良好的工作精神

Education and/or Experience/教育和/或经验.  Include the education and/or experience that is necessary to perform the job satisfactorily./ 包括满意地完成工作所必需的教育和/或经验

  N/A:  Intern or Co-op

1, Bachelor degree major in pharmaceuticals, chemistry ,medical device or related; /本科学历，制药、化学、医疗器械或相关专业;

2,  5 years above quality working experience in medcial device industry. /5年以上医疗器械行业质量工作经验。

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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