Director, Quality

Globus Medical

Audubon, PA, United States
Not specified
Global quality system strategy execution
Fda qsr and iso 13485 compliance
Sterile manufacturing validation oversight
Globus Medical is seeking a Director of Quality to lead their global quality systems, focusing on compliance and operational efficiency in the medical device sector. The ideal candidate will possess extensive experience in quality assurance and regulatory compliance, particularly within the medical device industry

Job Summary

  • The Director of Quality provides strategic leadership for the company's global quality systems ensuring alignment with product safety and effectiveness objectives.
  • This role requires direct responsibility for Quality Engineering, International Operations Quality, and Sterile Manufacturing Quality across all facilities and international markets.
  • The position drives a culture of accountability and continuous improvement while collaborating cross-functionally to maintain operational efficiency.

Matching Summary

Match Score: 85

Globus Medical is seeking a Director of Quality to lead their global quality systems, focusing on compliance and operational efficiency in the medical device sector. The ideal candidate will possess extensive experience in quality assurance and regulatory compliance, particularly within the medical device industry.

Skills & Requirements

Must-have

  • Global quality system strategy execution
  • FDA QSR and ISO 13485 compliance
  • Sterile manufacturing validation oversight
  • International regulatory audit management
  • CAPA and nonconformance process leadership

Nice-to-have

  • Lean Manufacturing and Six Sigma knowledge
  • Electro-mechanical device experience
  • Cross-functional collaboration skills
  • Proactive risk management culture
  • MDSAP and EU MDR expertise

Key Requirements

  • Minimum BS degree in Science or Engineering
  • 5+ years medical device QA/Quality Systems experience
  • Experience with FDA and CE Notified Body inspections
  • ASQ Certification or equivalent formal training desired
  • Knowledge of ISO 14971 and 21 CFR Part 820

Work Rights

Not specified

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