Job Description
Quality Management System:
Maintain effective quality management system to meet both local regulation and Agilent internation quality system requirements, including document /records control, NCR/CAPA/SCAR/Change control/quality trainings.
Operation Quality:
Coordinate the product quality management affairs for oversea imported medical device/in vitro diagnostic reagents, oversee the quality operation and quality performance for local external service providers.
Post market surveillance:
Support the product quality issue handling, including customer product complaints, medical device adverse events, field safety actions, etc.
Regulatory Compliance:
Support the regulation compliance initiatives, including China Medical Device regulation change monitoring, medical device distribution regulation compliance, and other local Medical Products Administration surveillance interaction initiatives.
Special Projects:
Take on projects related to the above responsibilities.
Qualifications
- Bachelor's degree or above, majoring in laboratory science relevant (including laboratory science, biomedical engineering, biochemistry, immunology, genetics, pharmacy, biotechnology, clinical medicine, medical devices, etc.), with "Advanced Medical Examination Technician Title" preferred.
- More than 5 years of experience in medical device quality management, prefer having mature experience in quality system or post market surveillance.
- Familiar with GSP / GMP and ISO13485 requirements.
- Strong quality awareness, able to handle multiple tasks parallelly, possessing problem-solving skills and cross function collaboration experience.
- English can be used as working language, proficient in using office software, and possessing strong learning and stress resistance abilities.
Additional Details
This job has a full time weekly schedule. It includes the option to work remotely.
Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at:
Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.
Travel Required:
Occasional
Shift:
Day
Duration:
No End Date
Job Function:
Quality/Regulatory