Qa Director, Herlev Site Leader

GE HealthCare Technologies

Herlev, Denmark
Not specified; not specified; relocation assistanc...
**
Bachelor's degree in scientific discipline
Extensive medical device industry experience
Proficiency with fda 21 cfr820 and iso 13485
** GE HealthCare is seeking a QA Director for their Herlev, Denmark site, responsible for leading quality assurance practices and managing a quality team to ensure compliance and effectiveness in medical device production. The role requires extensive experience in the medical device industry and a deep understanding of quality management systems and regulatory requirements. **

Job Summary

  • The QA Director will be responsible for creating a quality culture and driving compliance activities across the SVG Herlev site in Denmark.
  • This role requires managing a team of quality professionals while ensuring adherence to international regulatory requirements including FDA and EU MDR standards.
  • GE HealthCare offers relocation assistance and a total rewards package designed to support career growth within a global healthcare innovator.

Matching Summary

Match Score: 75

** GE HealthCare is seeking a QA Director for their Herlev, Denmark site, responsible for leading quality assurance practices and managing a quality team to ensure compliance and effectiveness in medical device production. The role requires extensive experience in the medical device industry and a deep understanding of quality management systems and regulatory requirements. **

Salary

Not specified; Not specified; Relocation assistance provided

Skills & Requirements

Must-have

  • Bachelor's degree in scientific discipline
  • Extensive medical device industry experience
  • Proficiency with FDA 21 CFR820 and ISO 13485
  • Knowledge of EU MDR Regulation 2017/245
  • Experience managing quality management systems
  • Ability to lead site level quality teams

Nice-to-have

  • Master's degree in Science or Business Administration
  • Strong commercial awareness and strategy influence
  • Excellent oral and written communication skills
  • Demonstrated project management leadership skills
  • Domain expertise in Design Controls and Risk Management

Key Requirements

  • Bachelor's degree in scientific discipline required
  • Master's degree preferred
  • Extensive working experience in regulated medical device industry
  • Proficiency with MS Office and Smartsheet applications

Work Rights

Not specified

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