Quality Control Lead

Location: California
* Review and approve Device History Records (DHRs) for sub-assemblies and Finished Goods (FG) to ensure compliance with GMP and procedural requirements.
* Review and approve RI documentation for completeness and traceability prior to material release.
* Audit calibration and PM records to ensure documentation accuracy and equipment qualification compliance.
* Maintain records in alignment with Good Documentation Practices (GDP) and submit them for document control archival.
* Minimum 5 years in Medical Device Quality Assurance or equivalent regulated industry.
* Proficient in 21 CFR Part 820, ISO 13485, and GDP/GMP.
* Experience in DHR review, receiving inspections, and use of basic measurement tools.
* Skilled in Microsoft Excel, QAD (or equivalent ERP), and electronic documentation systems.
* Strong attention to detail, time management, and problem-solving skills.

At iRhythm, you'll have the opportunity to grow your skills and your career while impacting the lives of people around the world. Together, we are reimagining the way cardiac arrhythmias are diagnosed. We need curious problem solvers like you. With opportunities remotely, at our office, in manufacturing, and in locations across the globe, this is your chance to meaningfully shape the future of cardiac health, our company, and your career.
** Driven By Purpose** - Cardiac health touches the lives of people all around us. Providing life-changing healthcare solutions that impact patients around the world drives us to bring our best every single day.
** Growth Means Opportunity** - We are growing rapidly. And with that growth comes a wealth of opportunities to learn and advance  potential to deepen your impact, seek new opportunities, and advance your career is yours to pursue.
** Build the Future** - We are a boundary-pushing organization that values innovative thinking and impacts healthcare at a global level. The expectation is to think big and build the future you see for iRhythm, our patients, and yourself.### Get In Touch Introduce yourself to our recruiters and we'll get in touch if there's a role that seems like a good match.
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