Senior Manager, Management Controls

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October 31

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iRhythm Technologies, Inc.

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Healthcare Insurance • Biotechnology • Medical Technology

iRhythm Technologies, Inc. is a medical technology company that specializes in digital healthcare solutions for the management of cardiac arrhythmias. The company is best known for its ZioSuite, a comprehensive platform designed to deliver a streamlined solution for assessing heart health through advanced analytics and patient-centered data collection. iRhythm focuses on improving patient outcomes and optimizing the efficiency of healthcare providers through innovative technology in the cardiac monitoring space.

1001 - 5000 employees

Founded 2006

⚕️ Healthcare Insurance

🧬 Biotechnology

📋 Description

• Lead and maintain iRhythm’s global Management Review process, ensuring compliance with US and international requirements. • Develop, implement, and continuously improve the Quality Planning process to align annual quality goals and initiatives with corporate and regulatory requirements. • Establish, monitor, and report Quality Objectives and Key Performance Indicators (KPIs) to evaluate QMS performance and drive accountability. • Lead ownership and oversight of the company’s electronic Quality Management System (eQMS), including system configuration, maintenance, validation activities, and process optimization. • Ensure the eQMS supports effective control of Quality System processes (e.g., CAPA, Complaints, Document Control, Training, Audit, etc.) and complies with global regulatory expectations. • Partner with global cross-functional leaders to ensure harmonized management control processes across all of iRhythm’s markets. • Coordinate preparation, accuracy, and traceability of data presented in Management Review and other Quality Systems data review presentations, ensuring actions are tracked to closure. • Maintain and improve the Quality Metrics program, ensuring consistent definitions, reliable data sources, and regular reporting cadence. • Support internal and external audits and inspections. Serve as the SME for Management Controls and eQMS validation during audits and inspections. • Identify and drive process improvement initiatives across Quality Systems to enhance compliance, data visibility, and operational efficiency. • Mentor and guide team members. Collaborates with mentors and motivates staff for success, provides coaching and development based on development needs. • Maintains QMS processes that are robust, alignment with corporate policies and procedures, and executed properly across all iRhythm sites. • Other duties may be assigned as deemed necessary by management.

🎯 Requirements

• Bachelor’s Degree or equivalent experience. • At least 10 years of experience in a Quality or Regulatory role, preferably in medical devices, with at least 7 years of experience working in the Quality System. • Direct experience in Quality System processes and project management. • Strong leadership presence with excellent communication (verbal and written) and interpersonal skills required. • Experience managing team projects, including experience as an active contributor on projects with scheduled deliverables. • Ability to manage complexity, analytical, and people management on a global basis. • Strong working knowledge of GxPs, ISO 13485 and 14971, and FDA and EU MDR regulations. • Strong analytical skills with demonstrated ability to troubleshoot complex process issues. • Attention to detail and timeliness are critical. • Able to provide quality service cross-functionally. • Ability and willingness to coach, mentor, and train employees. • Must operate through collaboration and transparency. • Must be a positive and energetic leader who is motivated to develop and grow a team with integrity.

🏖️ Benefits

• Health insurance • 401(k) matching • Paid time off • Flexible work arrangements • Professional development