Quality Speicialist

Johnson & Johnson Johnson & Johnson · Pharma · Suzhou, Jiangsu, China

Quality Specialist role at Johnson & Johnson in Suzhou, China, focusing on quality management systems, complaint handling, post-market surveillance, and risk management for medical devices. Responsibilities include data analysis, process improvement, supporting factory projects, and ensuring compliance with regulations like ISO13485 and GMP.

What you'd actually do

  1. As a Quality Specialist (Quality Engineer), responsible for collaborating with cross-functional teams in complaint handling, PMS, and risk management, and continuously improving quality management.
  2. Handle investigations of complaints for Ethicon local products according to complaint procedures and complete relevant complaint investigation reports in a timely manner. Use quality statistical techniques for data analysis and prepare monthly/quarterly/annual review reports.
  3. Cooperate with JJMS BQ, CAL, MA for Ethicon Suzhou product quality management after product launch.
  4. Monitor process capability continuously improvement by using appropriate statistical techniques
  5. Support factory projects from a quality perspective

Skills

Required

  • Bachelor's degree in Medicine/Biology/Chemistry or related fields
  • Familiar with ISO13485, GMP, medical device regulations, quality tools and statistical techniques
  • Good communication and learning ability
  • Fluent in English reading, writing and speaking
  • Familiar with conventional computer software operations

Nice to have

  • 2-3 years of quality work experience
  • Proficient in Microsoft applications such as Power BI, Power APP, Auto Flow
  • SAP operation experience

What the JD emphasized

  • ISO13485
  • GMP
  • medical device regulations