The Group Quality Director is responsible for formulating the company's overall quality strategy and ensuring the realization of strategic objectives under CEO leadership
Job Summary
The Group Quality Director is responsible for formulating the company's overall quality strategy and ensuring the realization of strategic objectives under CEO leadership.
This role requires deep expertise in medical device regulatory requirements and maintaining world-class quality management systems compliant with ISO13485 and FDA21CFR.
The incumbent must possess over eight years of experience in manufacturing quality management and proficiency in advanced process control tools like Six Sigma and FMEA.
Matching Summary
Match Score: 75
The Group Quality Director is responsible for formulating the company's overall quality strategy and ensuring the realization of strategic objectives under CEO leadership.
Skills & Requirements
Must-have
Deep knowledge of medical regulatory requirements
QMS experience in medical device manufacturing
Lead Auditor certification or experience
Proficiency in ISO13485 FDA21CFR IATF standards
Expertise in Six Sigma SPC MSA FMEA DOE tools
Over eight years in manufacturing quality management
Nice-to-have
Experience with Automotive Standards VDA6.3
Strong statistical ability and logical thinking
Fluent spoken English communication skills
Willingness to accept domestic and overseas assignments
Ability to coordinate cross-departmental cooperation
Key Requirements
More than eight years of experience in manufacturing quality overall management
Must have Lead Auditor experience
Proficient in ISO/TS systems including FDA21CFR and IATF