Senior Medical Device Quality Assurance Manager in China
5 days ago
We are seeking a Senior Medical Device Quality Assurance Manager to join our team in China. The successful candidate will be responsible for planning and delivering Life Science audit and consulting engagements related to quality/regulatory affairs infrastructure appropriate to the level of risk in a target product.
Key Responsibilities- Lead audits and consulting engagements in China, ensuring compliance with FDA/EUMDR regulations;
- Develop and implement quality systems plans, including design control and process validation programs;
- Collaborate with cross-functional teams to achieve superior client results;
- Travel extensively domestically within China, with occasional international travel required;
- Maintain knowledge of relevant EU Regulations, such as GMP and ISO 13485.
- Bachelor's degree in Engineering, Science, or life science-related field;
- At least eight years of experience with medical device or in vitro device manufacturing;
- Proven track record of leading audits and implementing quality systems plans under recognized life science standards;
- Demonstrated expertise in design control, process validation, and regulatory compliance, including FDA 21 CFR Part 803 and EU MDR;
- Experience working with Notified Bodies and interpreting codes, regulations, and standards in the medical device industry.
- Recognized certification as a Lead Auditor for ISO 13485 or equivalent;
- Experience with commercial-minded approach and ability to expand business where it makes sense for the client;
- Ability to work independently and collaboratively in a remote environment.
The estimated annual salary for this position is RMB 800,000 - RMB 1,200,000, depending on experience and qualifications. We offer a comprehensive benefits package, including health insurance, retirement plan, and paid time off.
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