Quality Speicialist-qs&cq

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. The role involves collaborating with cross-functional teams, analyzing data using statistical techniques, 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 areas such as complaint handling, PMS, and risk management, and continuously improving quality management.
  2. Handle investigation 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, 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 improve using appropriate statistical techniques
  5. Support factory projects from a quality perspective

Skills

Required

  • ISO13485
  • GMP
  • medical device regulations
  • quality tools
  • statistical techniques
  • Microsoft applications (Power BI, Power APP, Auto Flow)
  • SAP operation experience
  • Communication skills
  • Learning ability
  • Fluent English (reading, writing, speaking)
  • Familiarity with computer software

Nice to have

  • Administrative Support
  • Analytical Reasoning
  • Compliance Management
  • Data Capturing
  • Data Quality
  • Data Reporting
  • Data Savvy
  • Document Management
  • Problem Solving
  • Process Oriented
  • Quality Control (QC)
  • Quality Management Systems (QMS)
  • Quality Services
  • Quality Standards
  • Systems Analysis
  • Training People

What the JD emphasized

  • ISO13485
  • GMP
  • medical device regulations