Perform in process inspections per documented procedures, specifications, and engineering drawings. Ensure that all material received is in compliance with all appropriate documents and policies. Assist in managing MRB material. Assist in identifying, processing, and investigating non conforming products. Completes, maintains, and distributes appropriate Quality records a

Boldly innovating to create trusted solutions that detect, predict, and prevent disease. Discover your power to innovate while making a difference in patients' lives. iRhythm is advancing cardiac care...Join Us Now! At iRhythm, we are dedicated, self motivated, and driven to do the right thing for our patients, clinicians, and coworkers. Our leadership is focused and comm

Boldly innovating to create trusted solutions that detect, predict, and prevent disease. Discover your power to innovate while making a difference in patients' lives. iRhythm is advancing cardiac care...Join Us Now! At iRhythm, we are dedicated, self motivated, and driven to do the right thing for our patients, clinicians, and coworkers. Our leadership is focused and comm

Ensure the CAPA system is compliant with U.S. and applicable international Medical Device standards and regulations. Work alongside CAPA owners and stakeholders on assessing issue descriptions and ensuring containment, root cause analysis, correction, corrective and preventive actions, and effectiveness checks are appropriate, of high quality, and timely Support CAPA Boar

Your quality or clinical background and expertise in ISO 14971 will be utilized to strengthen the Organizational understanding and importance of applying proper Risk Management processes and techniques. You will lead Risk Management activities within product development (Design and Use), manufacturing processes (PFMEAs), and the post market surveillance phase. You will pr

Boldly innovating to create trusted solutions that detect, predict, and prevent disease. Discover your power to innovate while making a difference in patients' lives. iRhythm is advancing cardiac care...Join Us Now! At iRhythm, we are dedicated, self motivated, and driven to do the right thing for our patients, clinicians, and coworkers. Our leadership is focused and comm

Boldly innovating to create trusted solutions that detect, predict, and prevent disease. Discover your power to innovate while making a difference in patients' lives. iRhythm is advancing cardiac care...Join Us Now! At iRhythm, we are dedicated, self motivated, and driven to do the right thing for our patients, clinicians, and coworkers. Our leadership is focused and comm

The candidate selected for this role will Provide legal guidance and counseling to business and functional teams (such as sales and marketing, regulatory affairs, medical affairs, government affairs, patient access, clinical, quality, R&D, finance, and others). Proactively identify and manage regulatory legal risks for complex US or global issues and develop and approve a

Boldly innovating to create trusted solutions that detect, predict, and prevent disease. Discover your power to innovate while making a difference in patients' lives. iRhythm is advancing cardiac care...Join Us Now! At iRhythm, we are dedicated, self motivated, and driven to do the right thing for our patients, clinicians, and coworkers. Our leadership is focused and comm

Working knowledge of patents, trade secrets, copyrights and/or trademarks Draft and prepare legal documents appropriate to IP prosecution Docket and take appropriate action to monitor and meet USPTO prosecution deadlines, while coordinating with firm wide IP attorneys and paralegals on related matters Monitor applications and file responsive forms File replies or requests