Imricor Medical Systems - Quality Control

Seeking an experienced **Quality Systems Manager** in **Burnsville, MN** to own and enhance the QMS. Requires 10+ years in Quality Systems, 4+ in medical devices, and expertise in **ISO 13485, EU MDR, and 21 CFR 820**. You will lead internal audits, manage CAPA systems, and act as the primary int...

Quality Systems Specialist II needed in Burnsville, MN to manage CAPA, nonconformance, and audits in the medical device industry. Requires a Bachelor’s degree, 3-5 years of QA experience, and knowledge of ISO 13485 and 21 CFR Part 820. Drive compliance, lead root cause analysis, and improve quali...

Seeking a Senior Regulatory Specialist in Burnsville to lead US FDA and EU MDR submissions for medical devices. This role requires 5+ years of regulatory experience, expertise in 510(k) and CE Marking, and strong project management skills. We offer comprehensive benefits including medical, dental...

Join Imricor as a Senior Design Assurance Engineer in Burnsville. Ensure top-tier medical device quality by applying your expertise in design controls, risk management (ISO 14971), and regulatory standards (FDA, EU MDR). You will lead verification/validation and collaborate cross-functionally in ...