This role leads the identification, selection, certification, and monitoring of suppliers to ensure robust material and process quality within Johnson & Johnson's global supply chain
Job Summary
This role leads the identification, selection, certification, and monitoring of suppliers to ensure robust material and process 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 resolve complex supplier quality issues.
Candidates must possess deep expertise in Chinese medical device regulations (MAH) and active electronic component assembly to manage critical supplier relationships effectively.
Matching Summary
This role leads the identification, selection, certification, and monitoring 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 degree
GMP audit and supplier quality experience
ISO 13485 and QSR regulatory knowledge
CAPA and NCR investigation skills
Chinese medical device MAH experience
Active electronic component assembly experience
Nice-to-have
ASQ CQE or CSQP certification preferred
Six Sigma Black Belt or Green Belt
PMP or FPX project management training
FDA inspection experience
New product introduction experience
Bilingual English and Mandarin speaker
Cross-functional team leadership
Key Requirements
Bachelor's degree in Engineering or related field
Minimum 6 years experience in highly regulated industries
Direct GMP audit experience required
Knowledge of ISO 9001, ISO 13485, ISO 14971
Experience with FDA inspections preferred
Must have Chinese medical device MAH experience
Background in electronic components and active device assembly