Quality Engineer

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 https://www.jnj.com

Job Function:
Supply Chain Engineering

Job Sub Function:
Quality Engineering

Job Category:
Scientific/Technology

All Job Posting Locations:
Suzhou, Jiangsu, China

Job Description:

Under and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:


* Monitor all FGQA quality assurance functions.


* Establish and maintain appropriate documentation as required for Quality Assurance activities and the Quality Documentation Systems.


* Develop statistical sampling plans and perform process capability studies.


* Implement process control systems and provide technical support to process validations.


* Finish new test method protocol and report.


* Provide QS support in Product transfers and new products development.


* Assist in training new engineers, train technician and supervisors in process changes.


* Perform Complaint analysis investigation as needed.


* Participate in process/quality improvement projects.


* 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.


* Assist, review & approve non-conformances investigations & non-conforming product dispositions.


* 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.