Staff Source Quality Engineer

Johnson & Johnson

Suzhou, Jiangsu, China
6+ years regulated industry experience
Engineering or applied science degree
Gmp audit and supplier quality experience
This role leads the identification, selection, and certification of suppliers to ensure robust material and product 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 product quality within Johnson & Johnson's global supply chain.
  • The successful candidate will utilize advanced quality engineering tools like FMEA, SPC, and DOE to drive continuous improvement and risk reduction across vendor operations.
  • Candidates must possess deep expertise in medical device regulations including ISO 13485 and FDA requirements, with a specific preference for experience in the Chinese MAH market.

Matching Summary

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

Skills & Requirements

Must-have

  • 6+ years regulated industry experience
  • Engineering or applied science degree
  • GMP audit and supplier quality experience
  • ISO 13485 and QSR regulatory knowledge
  • CAPA and NCR investigation skills

Nice-to-have

  • FDA inspection experience
  • Six Sigma Black Belt certification
  • PMP or FPX project management training
  • ASQ CQE or CQA certification
  • MAH related experience in China

Key Requirements

  • Bachelor's degree in Engineering or Science
  • Minimum 6 years in highly regulated industry
  • Direct GMP audit experience required
  • Experience with electronic components assembly
  • Active work authorization in China

Work Rights

Not specified

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