Quality Operations Manager

J&J FAMILY OF COMPANIES

Ciudad Juarez, Chihuahua, Mexico
**
New product introduction validation strategies
Iso 13485 and qsr regulatory compliance
Capa and non-conformity investigation management
** Johnson & Johnson is seeking a Quality Operations Manager for its Ciudad Juarez location. The role involves overseeing quality assurance programs, leading quality improvement initiatives, and ensuring compliance with regulatory standards in the healthcare sector. **

Job Summary

  • This role leads quality assurance programs to ensure continuous production consistent with established standards in a medical device environment.
  • The position requires active participation as a Subject Matter Expert or Escort during regulatory agency audits such as FDA and BSI.
  • Candidates will drive business improvement initiatives using Six Sigma, Lean, and Kaizen techniques to reduce costs and enhance product quality.

Matching Summary

Match Score: 75

** Johnson & Johnson is seeking a Quality Operations Manager for its Ciudad Juarez location. The role involves overseeing quality assurance programs, leading quality improvement initiatives, and ensuring compliance with regulatory standards in the healthcare sector. **

Skills & Requirements

Must-have

  • New Product Introduction validation strategies
  • ISO 13485 and QSR regulatory compliance
  • CAPA and non-conformity investigation management
  • Six Sigma Lean Kaizen continuous improvement
  • Process validation and risk assessment FMEA
  • GMP production controls and audit preparation

Nice-to-have

  • Cross-functional collaboration with engineering
  • Strategic planning for quality objectives
  • Mentoring and team development skills
  • Innovative problem-solving capabilities
  • Benchmarking for quality method improvement

Key Requirements

  • Bachelor's degree in Engineering or applicable science
  • Master or Doctorate in applicable sciences preferred
  • 8 to 10 years of work experience required
  • Excellent English communication skills spoken and written
  • CQA CQE CQM CBA MBB or BB certifications preferred

Work Rights

Not specified

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