Responsibilities:
Responsible for raw material inspection and for establishing related procedures and inspection capabilities.
Responsible for quality control during the production process and for establishing related procedures and inspection capabilities.
Responsible for finished product inspection and for establishing related procedures and inspection capabilities.
Responsible for product release, including establishing release processes, reviewing and approving batch records according to the release process, and final product release.
Responsible for nonconformance handling, managing processes for handling nonconformities in procedures, documents, environment, equipment, processes, suppliers, and products; assessing nonconformance risks; and evaluating and approving nonconformance dispositions.
Responsible for laboratory management, including establishing laboratory management processes and testing capabilities; confirming and validating laboratory equipment; and developing and validating laboratory test methods.
Responsible for registration and filing of special laboratories and daily compliance management.
Responsible for equipment information management and equipment calibration.
Responsible for change evaluation and implementing corresponding action plans based on evaluation results.
Responsible for drafting and updating procedural documents, developing appropriate quality control procedures based on the latest regulatory requirements and actual needs.
Responsible for CAPA management, including root cause analysis, corrective and preventive action planning, implementation tracking, and effectiveness verification.
Responsible for conducting internal and external audits.
Responsible for quality management during project development phases.
Responsible for environmental monitoring in clean areas.
Responsible for collecting and analyzing operational quality-related data.
Responsible for work allocation within the operational quality team, as well as training and development plans.
Responsible for completing other related tasks as required by the company.
Qualification Requirements:
Bachelor’s degree or above in science or engineering; majors in biology, mechanical engineering, inspection, or medicine preferred.
Over 8 years of quality experience in medical manufacturing enterprises; experience in foreign-invested medical device manufacturing preferred.
Over 5 years of experience in production quality control and management.
Familiarity with GMP and ISO 13485 regulations.
Experience working in a GMP laboratory preferred.
Strong communication and teamwork skills.
Good English speaking and writing skills.
ISO 13485 internal auditor certification.
Proficient in common office software.
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com.
Top Skills
What We Do
Beckman Coulter is committed to advancing healthcare for every person by applying the power of science, technology, and the passion and creativity of our teams to enhance the diagnostic laboratory’s role in improving healthcare outcomes. Our diagnostic systems are used in complex biomedical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. Beckman Coulter offers a unique combination of people, processes and solutions designed to elevate the performance of clinical laboratories and healthcare networks. We do this by accelerating care with a menu that matters, bringing the benefit of automation to all, delivering greater insights through clinical informatics and unlocking hidden value through performance partnership. An operating company of Danaher Corporation since 2011, Beckman Coulter is headquartered in Brea, Calif., and has more than 11,000 global associates working diligently to make the world a healthier place.
