Not specified (assumed in-office based on job location).
New product introduction validation strategies
Iso 13485 and qsr regulatory compliance
Capa and non-conformity investigation management
Johnson & Johnson is seeking an NPI Quality Operations Manager in Ciudad Juarez, Mexico, to oversee quality assurance programs and ensure compliance with industry standards. The ideal candidate will have extensive experience in quality management, particularly in the medical field, and possess strong leadership and problem-solving skills
Job Summary
This role leads the quality assurance programs to ensure continuous production consistent with established standards for new medical products.
The manager is responsible for validating processes, managing regulatory audits including FDA interactions, and overseeing corrective actions for non-conformities.
Candidates will drive business improvement initiatives using tools like Six Sigma and Kaizen while ensuring compliance with ISO 13485 and QSR regulations.
Matching Summary
Match Score: 85
Johnson & Johnson is seeking an NPI Quality Operations Manager in Ciudad Juarez, Mexico, to oversee quality assurance programs and ensure compliance with industry standards. The ideal candidate will have extensive experience in quality management, particularly in the medical field, and possess strong leadership and problem-solving skills.
Skills & Requirements
Must-have
New Product Introduction validation strategies
ISO 13485 and QSR regulatory compliance
CAPA and non-conformity investigation management
Process validation and risk assessment (FMEA)
GMP and FDA audit preparation leadership
Nice-to-have
Six Sigma and Lean improvement techniques
Cross-functional collaboration with engineering
Strategic planning for quality objectives
Mentoring and team development skills
Benchmarking for quality cost reduction
Key Requirements
Bachelor's degree in Engineering or applicable science