2 remote jobs

The Manager of Operations/Quality Affairs, will be responsible for providing operational and quality leadership both strategically and in day-to-day activities. This individual will have sole responsibility for regulatory compliance related activities such as supplier management, change controls, deviations and general QMS maintenance. This individual will also ensure that the QMS and all business activities are in compliance with applicable US and international regulations and will be responsible for planning activities to ensure continued compliance.  This role requires the ability to develop and maintain cooperative working relationships with team members to effectively ensure compliance and timeliness of both (vendor) manufacturing and regulatory activities.   Responsibilities Manage the QMS to include CAPAs, Post-Market Surveillance, Training, Document and Change Control and Record Management. Manage audits (supplier audits as well as third-party, notified body or...

What and who we are:   UltraLinq is a SaaS cloud-based medical image solution. We give our clients the ability to read, store, report and archive medical images anytime and from anywhere with an internet connection. We are a mature SaaS company with a startup mentality. Our team solely consists of passionate, motivated problem-solvers dedicated to providing exemplary service to our customers as we improve the healthcare experience for healthcare providers and professionals. We nurture a casual, diverse, and energetic atmosphere with highly supportive co-workers. Who we need:   We are currently seeking a Regulatory and Quality Assurance Specialist to join our team in our New York, NY or Durham, NC office. This is a great position for someone who enjoys working as part of a small team and leading in the maintenance and expansion of regulatory processes. Why you should apply:   If you are looking to make a significant impact in the Quality and Regulatory Assurance space, this...