About this role
In this role, you will have the opportunity to:
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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)
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Support the line manager in delivering successful localization projects from a quality perspective in China.
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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.
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Provide and review Quality Agreements (QAA) for commercial teams and customers in a timely manner.
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Perform other quality-related duties as assigned by the manager. The essential requirements of the job include:
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Bachelor’s degree or above in healthcare and/or Lifesciences (medical device, chemistry, biopharma, pharma…) relevant.
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5-8 years’ experience of quality assurance and quality engineer experience. Familiar with GSP, GMP and/or ISO9001/13485 quality system requirements.
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Strong skills of problem solving.
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Have strong sense of responsibility as Quality Assurance Manager.
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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.