Staff Source Quality Engineer

J&J FAMILY OF COMPANIES

Suzhou, Jiangsu, China
6+ years highly regulated industry experience
Engineering or applied science bachelor degree
Gmp audit and supplier quality management
This role leads the identification, selection, and certification of suppliers to ensure robust material and process quality within Johnson & Johnson's global supply chain

Job Summary

  • This role leads the identification, selection, and certification of suppliers to ensure robust material and process quality within Johnson & Johnson's global supply chain.
  • The incumbent must possess deep expertise in Chinese medical device regulations (MAH) and active electronic component assembly to manage complex supplier relationships effectively.
  • Candidates are expected to utilize advanced statistical tools like FMEA, SPC, and DOE to drive continuous improvement and mitigate quality risks in a highly regulated environment.

Matching Summary

This role leads the identification, selection, and certification of suppliers to ensure robust material and process quality within Johnson & Johnson's global supply chain.

Skills & Requirements

Must-have

  • 6+ years highly regulated industry experience
  • Engineering or applied science bachelor degree
  • GMP audit and supplier quality management
  • ISO 13485 and QSR regulatory compliance
  • Chinese medical device MAH experience
  • Active electronic component assembly knowledge

Nice-to-have

  • FDA inspection experience preferred
  • Six Sigma Black Belt or Green Belt certification
  • ASQ CQE or CQA professional certification
  • PMP or FPX project management training
  • Bilingual English and Mandarin proficiency
  • New product introduction experience desired

Key Requirements

  • Bachelor's degree in Engineering or related field
  • Minimum 6 years experience in regulated industries
  • Direct GMP audit experience required
  • Knowledge of ISO 13485 and QSR regulations
  • Experience with Chinese Medical Device MAH system
  • Background in electronic component manufacturing

Work Rights

Not specified

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