Ortho2 is seeking a Quality Assurance and Regulatory Affairs Manager to be based in Ames, Iowa, who will be responsible for planning, directing, and/or coordinating quality and regulatory processes for certain components of our orthodontic software practice management suite of products.
Manage the FDA-QSR and ISO 13485 quality system requirements.
Ensure compliance with all applicable domestic and international regulatory requirements and quality system regulations and standards.
Review and monitor controlled records supporting the QMS.
Ensure all quality assurance systems and processes are being adhered to.
Coordinate preparation for internal and external audits and inspections.
Designated Representative (deputy) per FDA-QSR quality system requirements; specifically;
Ensure processes needed for the QMS are maintained and updated as needed.
Report to management on the performance of the QMS and any needs for improvement.
Ensure the promotion of awareness of regulatory requirements throughout the organization to any employees/stakeholders involved with the regulated products.
Coordinate Design Control activities as they relate to FDA-QSR and ISO.
Collaborate with internal teams to maintain and track standardized quality training for employees.
Ability to wear many “hats” in a small company environment where helping coordinate functions such as Design Control, technical report writing, and risk analysis will be needed.
Minimum Education Requirements:
Bachelor’s degree in science, engineering, or technical field preferred.
Desired Training and Experience Required:
2-3 years’ experience with Regulatory Affairs activities.
Knowledge of the FDA regulatory/quality processes and personal experience in working directly with regulatory and/or safety agencies (e.g., 510Ks, CE, UL, Notified Bodies, etc.).
Experience with FDA, QSR quality systems requirements – ISO experience recommended.
Excellent interpersonal, written and verbal communication skills.
Experience with software-based product – medical/dental software desirable.
Strong computer skills for maintaining an electronic Quality System.
Additional Salary Information: Opportunity for an annual performance based bonus.
Internal Number: 06112018QA
Ortho2 provides comprehensive orthodontic practice management software, imaging software, and communication solutions for orthodontists. We are the largest privately held orthodontic practice management software provider in the world. Our independence assures our stable orthodontic focus now and in the future.
Ortho2 is proud to offer two comprehensive orthodontic practice management systems – ViewPoint™ and Edge™. Edge Management, Imaging, and Communication System provides secure Cloud Computing technology, an off-site data hosting system that replaces your on-site network servers. This simple, convenient feature allows you to fully access this secure web-based data infrastructure from anywhere on any platform.
Edge Imaging software offers one of the most advanced imaging technologies available today with an intuitive interface, comprehensive features, and easy functionality. Edge Animations is a collection of powerful videos used to enhance patient education, compliance, and case presentation. These are just two of the advanced options available inside both ViewPoint and Edge.