Pall Beijing plant QARA engineer

Reposted 20 Hours Ago
Be an Early Applicant
Beijing, CHN
In-Office
Mid level
Healthtech • Other • Software • Biotech
The Role
Manage China-specific quality and regulatory activities: monitor laws, record & report market nonconformities, complete product testing/certification, maintain database records, prepare Chinese labels, support audits and CAPA validation, and communicate requirements to global QARA and internal stakeholders.
Summary Generated by Built In
  • 及时准确传达Pall总公司业务中与Pall China相关的政策规定,协助建立相应的内部政策并监督其执行。

Purse Pall Global quality policy which relative to Pall China , inform and assist to establish internal policy and supervise implementation.

  • 及时了解中国法律法规变化,向Pall总公司的QARA及时汇报,并协助其制定相应政策。

Purse the change of Chinese laws and regulations and report to global QARA timely and assist to establish policy.

  • 100% 记录在中国市场发生的Energy+不一致品抱怨,及时和IC、销售、客户及各Share Service部门沟通并传递相应信息,定期汇总报告

100% record nonconformity from China Energy+ market, communicate with IC ,sales, customer and our share service department timely. Report period.

  • 按计划完成进口产品的检测,认证工作,并及时上传到数据库中。

Complete test and validation work as schedule and update to database on time.

  • 定期与检测机构交流沟通,了解新规范新要求,实际向公司相应部门传达。

Communicate with test institute to acknowledge new requirement and transfer to relevant department.

  • 在收到销售通知的两个工作日内完成中文标签的转化工作,提供给销售以便发货。

Provide Chinese label in 2 days to sales.

  • 定期检查现有进口产品是否满足现行法律法规要求。

Review if the import product meet current laws and regulations requirement period.

  • 收到系统通知时即使进行数据库操作,定期回顾,保证审核按时完成。

Finish operation in database when received notification, and review period to push approval work complete in time.

  • 收到质量文件要求时,及时准确的提供相应文件。

Provide quality document timely and correctly when required.

  • 按照计划协助完成内审并按时回顾验证其措施。

Organize external and internal audit, assist customer audit and CAPA validation.

  • 及时准确反馈上级QARA的要求,按计划完成新产品认证工作。

Response senior QARA requirement ASAP, and finished certificate work for new product according to plan.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

Skills Required

  • Knowledge of Chinese laws and regulations relevant to imported products and medical/energy+ products.
  • Experience with product testing, certification, and validation processes for imported products.
  • Ability to maintain and operate quality/regulatory databases and upload certification records timely.
  • Experience conducting or supporting internal and external audits and CAPA validation.
  • Strong communication skills to liaise with global QARA, test institutes, sales, customers, and shared service departments.
  • Ability to produce accurate Chinese product labels within two business days.
  • Timely preparation and provision of quality documentation upon request.
  • Record-keeping and reporting of market nonconformities and complaints (100% recording requirement).

Beckman Coulter Diagnostics Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Beckman Coulter Diagnostics and has not been reviewed or approved by Beckman Coulter Diagnostics.

  • Healthcare Strength Healthcare coverage is described as comprehensive, including medical, dental, vision, life and disability insurance, flexible spending accounts, and mental health support. Feedback suggests these offerings are a notable strength of the overall package.
  • Leave & Time Off Breadth Paid time off, paid holidays, sick days, and volunteer time are highlighted, with flexibility or remote arrangements available for some roles. Feedback suggests this breadth of time-off options contributes meaningfully to total rewards.
  • Parental & Family Support Paid parental leave is provided for birth, adoption, or foster placement with the ability to use time in flexible increments within the first year. Feedback suggests family-focused perks like adoption support add tangible value for caregivers.

Beckman Coulter Diagnostics Insights

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The Company
HQ: Brea, CA
10,526 Employees
Year Founded: 1935

What We Do

Beckman Coulter is committed to advancing healthcare for every person by applying the power of science, technology, and the passion and creativity of our teams to enhance the diagnostic laboratory’s role in improving healthcare outcomes. Our diagnostic systems are used in complex biomedical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. Beckman Coulter offers a unique combination of people, processes and solutions designed to elevate the performance of clinical laboratories and healthcare networks. We do this by accelerating care with a menu that matters, bringing the benefit of automation to all, delivering greater insights through clinical informatics and unlocking hidden value through performance partnership. An operating company of Danaher Corporation since 2011, Beckman Coulter is headquartered in Brea, Calif., and has more than 11,000 global associates working diligently to make the world a healthier place.

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