SCOPE OF THE ROLE AND BASIC PURPOSE
-This job description covers the skills & responsibilities for the R&D Quality Engineer that will be located in the China R&D facility. It includes the following levels: Engineer (no designation), Senior.
-Assisting in the development and continuous improvement of Quality Systems for China R&D in alignment with regional and franchise objectives.
-Ensuring project team compliance with the Suzhou and Franchise Quality Management Systems, government regulations & international standards requirements
-Supporting product development efforts by preparing quality plans, reviewing design plans, -overseeing qualification, risk management & validation processes, and ensuring appropriate control plans are provided for design transfer.

Required Competencies and Skills
-Education / Degree Required: Bachelor or above in engineering or scientific discipline
-Job Experience: 4 years + focus in R&D Quality area, if senior require 7 years+
-Bilingual: English/Mandarin required
-Team interpersonal: partnering, interaction, feedback, negotiating, training
-Effective team interpersonal skills and the ability to work effectively within diverse cultural environments.
-Reliability & quality engineering
-Oral & written communication in Mandarin and English
-Quality assertiveness and quality mindedness
-Analytical & creative thinking
-Project management—support multiple projects simultaneously
-Problem-solving & priority setting
-Organizational —can synthesize information from a variety of sources
-Capable—understand new concepts quickly
-Auditing—against ISO (International Organization for Standardization), QSR (Quality Systems Regulations) & GMP (Good Manufacturing Practices) standards
-Research— maintain on-going learning of industry, regulations
-Knowledge of:
Regulatory compliance: GMP (Good Manufacturing Practices),GLP (Good Laboratory Practices), MDD (Medical Devices Directive), 510K (Pre-market Notification)
Government, trade association, industry & medical publications
Statistics and Process Excellence Skills
Product design and manufacturing for Medical Devices

Mail: Qhuang6@its.jnj.com