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Danaher Corporation

QA Supervisor

Danaher Corporation Shanghai, Shanghai, China

Biotechnology Research · 10,001+ employees

Yesterday
qa Senior (5-10 yrs) Full-time China
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About the role

The QA Supervisor will manage GSP-related policy and compliance affairs for medical devices while supporting localization projects from a quality perspective. They will also lead post-market QA activities, internal/external audits, and maintain the Quality Management System.

What they look for

Quality Assurance GSP GMP ISO 9001 ISO 13485 Problem Solving CAPA Quality Management System Internal Auditing External Auditing Regulatory Compliance Cross-functional Communication Project Management Medical Devices Quality Agreements

Requirements

Candidates must hold a bachelor's degree or higher in a healthcare or life sciences field and possess 5-8 years of quality assurance experience. Proficiency in GSP, GMP, and ISO quality standards is required, along with strong problem-solving and communication skills.

Full description

In this role, you will have the opportunity to:

  • Manage GSP-related policy and compliance affairs for Cytiva medical devices. (i.e. Compliance with Shanghai MPA and Pudong Market Bureau requirements, Ad Promo Material filing as needed)
  • Support the line manager in delivering successful localization projects from a quality perspective in China.
  • Lead or contribute to post-market QA activities and internal/external audits, with a focus on driving continuous improvements such as timely delivery of CAPAs and maintaining the QMS.
  • Provide and review Quality Agreements (QAA) for commercial teams and customers in a timely manner.
  • Perform other quality-related duties as assigned by the manager.

The essential requirements of the job include:

  • Bachelor’s degree or above in healthcare and/or Lifesciences (medical device, chemistry, biopharma, pharma…) relevant.
  • 5-8 years’ experience of quality assurance and quality engineer experience. Familiar with GSP, GMP and/or ISO9001/13485 quality system requirements.
  •  Strong skills of problem solving.
  • Have strong sense of responsibility as Quality Assurance Manager.
  • Fluently communicate in English in written and/or oral.

It would be a plus if you also possess previous experience in:

·         Qualified the Internal auditor of ISO9001 or ISO 13485

  • Fast learner with good cross functional communication and collaboration capabilities

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.

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