Job Responsibilities
Implement, manage and constantly improve the companys quality management system, including but not limited to the IVD products and equipment.
Perform incoming, in-process and final QC inspection.
Regularly perform internal audits, compile audit reports, problem analysis reports, improvement proposals, and monitor the rectification plan and its implementation.
Lead and Participate in the internal audits and management reviews of the company's quality system as key member of company's quality department.
Manage the system and documents of companys quality management system, including but not limited to the IVD products and equipment.
Be specifically responsible for the IVD equipment quality management system.
Statistical analysis of IVD equipment quality data, and draft reports and corrective and preventive measures.
Update quality standards, laws and regulations and publish company quality policy.
Establish collaborative and cooperative working relationship with key opinion leaders and the regulatory bodies.
Collaborate with cross-functional teams to meet projects goals with overall organizational objectives.
Any other ad-hoc duties or projects as required by the management team.
Requirements
Majoring in biology, medicine, laboratory science, immunology, pharmacy or quality engineering are preferred.
A bachelor's degree with 2 years of relevant experience, others are welcome to apply.
Quality system related training and internal auditor training.
Familiar with US FDA 820 & ISO13485 quality management system and ISO 13485 certification work, experience with successful case(s) will be preferred.
Familiar with medical device industry standards and specifications.
Strong quality management system knowledge and capabilities.
Familiar with in vitro diagnostic products such as lateral flow immunoassay, PCR, Immunoassay etc.
Familiar with IVD product development and commercialization life cycle.
Systematically project management, good planning, execution and timely communication. Good presentation skills.
Enthusiastic, proactive, and down-to-earth work attitude, strong communication & execution ability, results driven, and a team player.
Meticulous and strong sense of responsibility; able to handle stress and tight schedule.
