Guardant Health Inc is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. Its Guardant Health Oncology Platform is designed to leverage its capabilities in technology, clinical development, regulatory and reimbursement to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs.

Essential Duties and Responsibilities:

Quality Assurance (QA and QMS)

• Collaborates with quality manager and responsible for maintaining and configuration of QMS and ISO13485, in accordance with change control processes
• Leads the company's compliance activities according to ISO13485/ 15189, CAP/CLIA, and applicable requirements.
• Maintain and manage both of MAH and Laboratory QMS
• Performs track and trend analysis on quality data and takes the necessary actions to mitigate risk
• Oversee the risk management process and oversee its related activities
• Communication with the regulatory authorities and notified body
• report and respond to related regulatory authorities.
• Ensure that all SOPs are written in accordance with applicable regulatory and company requirements
• Demonstrates an understanding of quality concepts such as: cost of quality, analytical metrics and / or statistics, trending, quality planning, validation, CAPA and problem solving.

• +3year experience of Quality Assurance in the medical device industry
• Bachelor’s degree in a scientific discipline
• Business English (verbal and written)

Preferable:

• Experience of Communication and/or Negotiation with the Regulatory Authorities
• Experience of External Auditor
• Experience and knowledge of ISO13485、ISO15189、ISO14971、CAP（College of American Pathologists）,CLIA (Clinical Laboratory Improvement Amendments) and software-lifecycle
• Experience of Start-up Business
• Oversea Business trip

Guardant Health Inc is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

#LI-TH2