QA Director (Medical Devices, Herlev)

Job summary

The QA Director will oversee the quality team and strategy at the Herlev site, focusing on developing and implementing quality assurance practices to ensure the production of safe and effective products.

Responsibilities

• Foster a quality culture by managing compliance activities and driving quality metrics. Ensure adherence to quality and regulatory standards while enhancing process efficiency. Act as the representative for external agencies and promote quality objectives and reporting mechanisms.
• Lead a small to medium-sized team of quality professionals, influencing strategy and resource management within the quality domain.
• Provide direction for quality initiatives, including product quality enhancements, and represent management during quality audits and customer interactions.
• Guide functional teams or projects, communicating complex concepts and influencing perspectives.
• Utilize evaluative judgment to make decisions on complex tasks, assessing information quality and proposing innovative solutions.

Qualifications

• Bachelor's Degree in a scientific field; Master's in Science or Business Administration preferred; extensive experience in the medical device or regulated industry.
• Strong understanding of Medical Device QMS and international regulatory requirements, including FDA regulations and ISO standards.

Skills

• Excellent oral and written communication skills, strong leadership and interpersonal abilities, problem-solving skills, and project management expertise.
• In-depth knowledge of quality management systems, particularly in Design Controls, Software Development, and Risk Management.

Education

• Bachelor's degree in a scientific discipline required; Master's degree preferred.

Tools

• Proficiency in MS Office applications, Smartsheet, and database management tools.