Johnson & Johnson Careers
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Senior R&D Quality Engineer
Requisition ID: 1805653380W
• 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 +
▪ 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
▪ Extensive experience with ISO 13485/ 14971 and QSR Design Control standards
▪ Self-managed—work with minimal supervision and can respond to complex problems on own
▪ 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
Johnson & Johnson Medical Suzhou Ltd. (7054)