QA Director (Medical Devices, Herlev)

Job summary

The QA Director is responsible for overseeing the quality team and strategy at the Herlev site, focusing on the development and implementation of quality assurance practices to ensure the production of safe and effective products.

Qualifications

• Bachelor's Degree in a scientific discipline; Master’s in Science or Business Administration preferred.
• Extensive experience in the medical device industry or regulated industry.
• Knowledge of Medical Device QMS requirements and international regulations (e.g., FDA 21 CFR820, ISO 13485, EU MDR).
• Proficiency in MS Office, Smartsheet, and database applications.

Responsibilities

• Foster a quality culture by managing compliance activities and driving quality metrics.
• Lead a team of quality professionals and influence strategy development within the quality domain.
• Direct quality initiatives and represent the organization during quality audits.
• Guide teams in achieving service and quality objectives while advising management on functional policies.
• Utilize judgment to solve complex problems and provide innovative solutions.

Skills

• Strong communication and leadership skills.
• Ability to analyze and resolve issues effectively.
• Established project management capabilities.
• Expertise in quality management systems, Design Controls, Software Development, and Risk Management.

Education

• Bachelor's Degree in a scientific discipline; Master’s preferred.

Tools

• MS Office Suite, Smartsheet, database applications.