Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

How will you make an impact?

Thermo Fisher Scientific's R&D team in China is a vital part of our global effort to serve science and drive innovation. By joining our team, new hires will have the outstanding opportunity to contribute to new product development projects that have a profound impact on global health and environmental sustainability. Whether developing innovative scientific instruments, groundbreaking medical devices, or improving quality management systems, your work will be integral to achieving our mission. Together, we can drive scientific discovery, improve healthcare outcomes, and ensure a cleaner, safer world for future generations.

Responsibilities:

Take charge of coordinating and managing the Quality Management System (QMS) documentation for all R&D projects.Maintain and archive Design History Files (DHF) to ensure compliance with internal New Product Development process and regulatory requirement.Collaborate with the R&D team to collect, review, and coordinate project documentation.Ensure all design and development records are accurate, complete, and up-to-date.Support internal and external quality audits by providing vital documentation and records.Implement document control procedures for continuous improvement of efficiency and compliance.Assist in the development and maintenance of quality processes and procedures.Provide training and support to R&D team members on documentation control and QMS requirements.Supervise and report on the status of project documentation and compliance activities.Identify and address any documentation gaps or non-conformities.

Qualifications:

Bachelor’s degree in Engineering, Quality Management, or a related field.Proven ability in quality engineering, preferably in the medical device or scientific instrument industry.Strong understanding of ISO13485 and ISO9001 standards.Experience with Quality Management Systems (QMS) and document control processes.Excellent interpersonal and record-keeping skills.Diligent with a strong dedication to maintaining high-quality standards.Ability to work independently and manage multiple projects simultaneously.Proficiency in using documentation management software and tools.Certification in quality management (e.g., CQE, CQA) is a plus.Experience with electronic document management systems.Familiarity with regulatory requirements for science instruments and/or medical devices.