Commercial Quality Specialist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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Job Description:

• • Perform quality support duties including maintenance of Document management and training management. 
• • Build QMS quality system cased on regulatory and J&J requirements; PMS supervision and handling (AE/complaints/field action).
• • Provides support for special quality projects. Ensures and maintains a state of inspection readiness. 
• • Performs in various quality functional areas and maintain expertise. Adheres to environmental policy, procedures, and supports department environmental objectives.
• • Perform and coordinate the complaint handling and investigations, both locally and in cooperation with AMO foreign manufacturing sites;
• • Responsible for complaint handling/ AE reporting / PRER
• • Handle the regional non-conformance cases as required
• • Draft and update the quality procedures and perform the quality training per NMPA medical device business regulation.
• • Set up the regional QMS based on JJSV division quality project;
• • Manage the recall/field corrective action when required.
• • Work with RA to prepare the artwork of Chinese labeling for products.
• • Responsible for training and quality culture development
• • Document coordinator (Agile System)
• • Facilitate to execute internal audit and external audit when required.
• • Lead to do NC/CAPA in responsible area
• • Responsible for building and maintaining procedure of responsible process per applicable regulation & J&J requirements
• • Other system supporting, such as REF distributor qualification, Supplier management, Change control management, UDI management
• • Complete other tasks assigned by the manager

Required Skills:

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