Quality Assurance Specialist

5 hours ago


Sunnyvale, California, United States Intuitive Full time
Job Description

We are seeking a highly skilled Quality Assurance Specialist to join our team in China/Hong Kong. As a key member of our quality team, you will play a pivotal role in ensuring compliance with China's National Medical Products Administration (NMPA) Quality Management System (QMS) requirements.

This position supports our strategic priorities in China, facilitates communication between our company and its joint venture (JV) with Fosun Pharma, and drives NMPA regulatory compliance efforts. The role encompasses QMS compliance throughout the product lifecycle, including remediation planning, execution, and continuous improvement.

The ideal candidate will have a minimum of 8+ years of working experience in Quality System or related field, with a strong background in medical device industry (China QMS a plus). They should be familiar with NMPA Decree 739, US FDA requirements (CFR 21 Part 820), and ISO 13485 QMS standards.

A competitive salary of $120,000 - $180,000 per annum is offered for this position. Benefits include market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity.



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