Not specified; not specified; relocation assistanc...
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Bachelor's degree in scientific discipline
Extensive medical device industry experience
Proficiency with fda 21 cfr820 and iso 13485
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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.
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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
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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.
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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