Quality Engineer

Quality Engineering

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.

Job Function: Quality Engineering

Job Category: Scientific/Technology

All Job Posting Locations: Suzhou, Jiangsu, China

Job Description:

• Establish and maintain appropriate documentation as required for Quality Assurance activities and the Quality Documentation Systems.
• Maintain and improve incoming, in-process quality control, finish good release procedure, provide technical support of process validations and risk management control.
• Responsible for inspection instrument qualification and test method validation.
• Provide Quality support in product transfers project, in terms of cooperate with local and global team to deliver Quality talks.
• Perform investigation of NC, CAPA, complaint, observation investigation as needed;
• Review NCR and disposition of nonconforming products.
• Assist in training of production and inspectors on quality knowledge.
• Participate in process/quality improvement projects.
• Develop and implement appropriate process monitoring and control methods to maintain consistency with process/product risk
• Support COGs initiatives.
• Responsible for following and administering safety.
• Compliance with safety policies and procedures.
• Follow J &J and Ethicon Records Management Policies for Convenience information, Records Retention Schedules, Training and Education, Document Hold Notices, Records Cleanout, Inactive Records and Information Management, Vital Records and the third-party vendor if applicable.
• Provide as needed, subject matter expert feedback on manufacturing process changes.
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed.