Senior Quality Assurance Expert Medical Devices
10 hours ago
We are seeking a highly skilled Senior Quality Assurance Expert to join our team at Vision Achievement. In this role, you will be responsible for leading medical device audits and consulting engagements in China.
Key Responsibilities:- Plan and deliver Life Science audit and consulting engagements related to quality/regulatory affairs infrastructure.
- Work with clients to identify areas for improvement and implement corrective actions.
- Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
- Develop and maintain strong relationships with clients to ensure their needs are met.
- Bachelor's degree in Engineering, Science, or life science related field.
- At least 5 years of experience working as a lead auditor in the medical device industry in China.
- Proven track record of delivering high-quality results and meeting client expectations.
- Strong knowledge of FDA regulations and ISO 13485 standards.
- Excellent communication and interpersonal skills.
- At least 8 years of experience with medical device or in vitro device manufacturing.
- Experience with quality systems planning and implementation under recognized life science standards.
- Experience working with Notified Bodies is a plus.
- Experience with design control and process validation program development and implementation.
This role requires extensive travel within China, with occasional international travel required.
Estimated Salary: ¥450,000 - ¥600,000 per year, depending on experience.
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