Irhythmtech
Quality Control Manager
Orange County, CA
Sponsorship not specified$112k-$145kDetected 30 days ago
AlgorithmsData AnalysisCompliancePatient CareFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationMentoringOrganizational Skills
About the role
- Establishes clear ownership of shop-floor quality execution
- Reduces compliance and audit risk related to inspection, documentation, and material control
- Enables scalable manufacturing growth while maintaining product quality and regulatory compliance
Responsibilities
- Lead, coach, and develop Manufacturing Quality Inspectors and Receiving Inspection personnel.
- Inspection Strategy & Manufacturing Quality Support
- Support the development, implementation, and continuous improvement of inspection plans, sampling strategies, and control plans in collaboration with Quality Engineering, Supplier Quality and Manufacturing Engineering.
- Drive improvements to inspection efficiency, first-pass yield, and defect containment across manufacturing operations.
- Nonconformance, MRB & Planned Deviation Support
- Support and participate in Material Review Board (MRB) activities, ensuring accurate disposition execution and documentation.
- Support planned deviations to maintain production continuity while ensuring risk assessments, approvals, and documentation are completed per the Quality Management System.
- Own the review, verification, and acceptance of manufacturing batch records and travelers to ensure completeness, accuracy, and compliance prior to lot release or handoff.
- Every day, we collaborate, create, and constantly reimagine what's possible.
Requirements
- Verify that all required inspection results, testing reports, in-process checks, deviations, nonconformances, and MRB dispositions are properly documented and approved within the batch record or traveler.
Nice to have
- Ensure equipment is calibrated, maintained, and suitable for its intended use prior to release for production or inspection.
- Ensure QC operations comply with ISO 13485, QSMR/FDA 21 CFR 820 and applicable internal SOPs, DOP's and work instructions.
- Monitor QC-related metrics and trends to proactively identify compliance risks and improvement opportunities.
- Continuous Improvement & Gemba Leadership
- Bachelor's Degree in Life Sciences, Engineering, or a related technical discipline is required
- Master's Degree is preferred.
- Strong working knowledge of ISO 13485, FDA 21 CFR Parts 820, with working familiarity of EU MDD and EU MDR requirements.
- Demonstrated ability to identify, investigate, and resolve complex quality and manufacturing issues, including nonconformances, MRB activities, deviations, and corrective actions.
Compensation
- Estimated Pay Range
Benefits
- Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career
- iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease.
- Through a relentless focus on patient care, iRhythm's vision is to deliver better data, better insights, and better health for all.
Company info
- As a part of our core values, we ensure an inclusive workforce.
Equal opportunity
- Equal Opportunity Employer.
- If you need such an accommodation, you may contact us at taops@irhythmtech.com
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This listing is sourced directly from Irhythmtech's careers page and normalized into a canonical job model.