Description:
iRhythm Technologies is seeking a Quality Operations Manager to oversee quality control, compliance, and quality management systems at its Deerfield, IL facility. This role is critical in ensuring product quality, regulatory compliance, and continuous improvement in clinical operations and reverse logistics intake operations. The Quality Operations Manager will lead external audits (FDA, Notified Bodies), manage non-conformance investigations, and drive process enhancements in collaboration with supply chain and clinical teams.
Key Responsibilities:
- Oversee quality control, reverse logistics, product investigations, and compliance processes.
- Manage non-conformance processes (MRB, planned deviations, complaint investigations, CAPAs).
- Ensure site inspection readiness and host regulatory audits (FDA, Notified Bodies).
- Lead quality improvement initiatives and collaborate with supply chain teams to enhance product quality.
- Maintain and implement site-specific Quality Management System (QMS) aligned with iRhythm’s global QMS.
- Provide quality oversight for clinical operations, ensuring adherence to regulatory standards.
- Serve as a liaison with iRhythm’s Independent Diagnostic Testing Facility (IDTF).
- Define and track quality metrics to drive continuous product and system improvements.
- Partner with leadership to foster a culture of quality, compliance, and operational excellence.
Qualifications:
- Bachelor’s degree in Science, Engineering, Computer Science, or a related medical/science field.
- 7+ years in quality and regulatory roles within the medical device industry.
- Experience in medical device compliance, design control, risk management, and QMS implementation.
- Strong knowledge of FDA regulations (21 CFR 820), ISO 13485, ISO 14971, and GMPs.
- Experience in leading regulatory audits (FDA, EU Notified Bodies).
- Strong analytical, organizational, and leadership skills in a fast-paced, collaborative environment.
Benefits & Perks:
- Competitive salary & benefits (medical, dental, vision, 401K w/ company match).
- Employee Stock Purchase Plan and paid time off.
- Annual company events & cultural initiatives.
- Diverse and inclusive work environment with career growth opportunities.