Minimum of Engineering Degree, or equivalent in related field. 4 to 5 years of experience with design controls and device risk management documentation. 100% travel flexibility required.
• Experience with Design History File building and enhancements for on-market products
• Ability to work within multi-disciplinary teams while maintaining and prioritizing own workload with minimal supervision
• Exceptional attention to detail with the ability to quickly learn and apply established procedures in a consistent manner
• Knowledge and understanding of the development and operation of equipment, devices, and/or manufacturing processes through designed experiments
• Proficiency with quality and regulatory requirements as it relates to medical devices
• Software proficiency in Word, Excel and SharePoint
Headquartered in Chicago metropolitan area, Protocol Link is a leading project management and strategy consulting firm providing comprehensive regulatory affairs, cGMP compliance, quality assurance, and validation services to the FDA-regulated companies worldwide. Protocol Link’s mission is to provide customer-focused services with ethical conduct, mutual trust, and personnel empowerment while striving to offer the best of both quality and efficiency. It's how we've been doing business since 1996. The right way.