Title: Director of Quality
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Summary:
Are you a Quality leader looking for an opportunity to join a fast-paced, emerging medical device company? Are you interested in overseeing multiple sites and managing various groups of people? One of the world's leading medical device companies, with a diverse portfolio in vascular and IV access, including anesthesia, urology and cardiac care, are looking for a Director of Quality for their global operations.
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The Director of Quality will:
Ensure compliant quality systems that meet business standards at US and International manufacturing plants, including ISO13485, 21CFR Part 820, EU MDR and Japanese Pharmaceutical Affairs law
Oversee and manage product QA activities
Lead a diverse group of employees while constantly developing and adapting to business needs
Supporting Supplier Quality Management, Procurement, Sterilization and Microbiology teams
Expertise in US and international regulations, standards and guidance documents
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The Director of Quality should have the following experience:
Bachelor's Degree in Science, Engineering, Pharmacy or related space.
At least 12 years of experience in a quality function with 8 years of leadership experience
Extensive knowledge of US Quality System Regulations and ISO13485 quality system requirements
Audit experience for various regulatory bodies
Multi-plant operation management in compliance with US and international regulations
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If this sounds like something that you would be a great fit for, please do not hesitate to apply!
