Helping medical device Sponsors improve healthcare since 1967, NAMSA is the world’s leading MedTech Contract Research Organization (CRO) offering global end-to-end development services. Driven by its global regulatory expertise and in-depth therapeutic knowledge, NAMSA is dedicated to accelerating medical device product development, offering only the most proven solutions to move clients’ products through the development lifecycle efficiently and cost-effectively. From medical device testing; regulatory, reimbursement and quality consulting; and clinical research services, NAMSA is the industry’s premier, trusted partner for successful development and commercialization outcomes. Learn more: https://namsa.com/about/client-testimonials
Director, Global CRO Quality
Location
Ohio + 1 moreAll locations: Ohio, Minnesota
Posted
22 days ago
Salary
$121.2K - $175K / year
Job Description
Job Requirements
- Bachelor’s degree or higher
- At least ten years of experience in quality assurance or clinical research with human subjects and Quality Management systems( QMS)
- ASQ, SQA or equivalent certification preferred
- Demonstrated ability to establish and maintain relationships with clients and internal Associates
- Knowledge of appropriate regulations and guidelines, especially ISO 9001:2015, ISO 14155, 21 CFR Parts 11, 312 and 812, MedDev, EUMDR, GDPR, and 21 CFR Parts 11, 50, 54, 56 and 812.
- Proficiency with standard computing (PC or Mac) and basic software application.
- Proficiency with process development and technical writing.
- Must be able to work independently and autonomously.
- Must possess excellent verbal and written communication skills.
- Strong organizational skills with attention to detail.
- Demonstrate a high degree of personal and professional integrity.
Benefits
- Relocation will be considered
- Extensive use of a computer keyboard
- Some travel required 15%
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