Quality Operations Manager at iRhythm Technologies

Deerfield, Illinois, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Bachelor's degree required in Science, Engineering, Computer Science, or related medical/science/healthcare field or equivalent experience
Minimum of 7 years of professional experience in quality and regulatory roles in the medical device field
Strong knowledge of medical device GMPs, design control, and risk management processes and regulations, including software as a medical device
Previous experience working in highly regulated environments directly with regulatory agencies such as FDA and EU Notified Bodies
Previous knowledge of regulations and standards such as ISO 13485, ISO 14971, FDA 21 CFR 820
Previous experience with participation in and/or hosting external regulatory and/or third-party audits
High-level analytical skills and ability to focus on detail
Proven capacity to collaborate and build positive relationships and trust over time

Responsibilities

Oversee the management of day-to-day site Quality Operations activities, including Quality Control, Reverse Logistics including intake operations, product quality issues investigations, planned deviations, and non-conformances
Handle Complaint Investigations, as applicable
Manage site Calibration processes, as applicable
Responsible for site Non-Conformance and MRB processes
Responsible for site calibration processes
Responsible for the execution of site-specific inspection readiness programs
Define & Monitor Site Quality Operations metrics to drive product and system quality improvements
Ensure the implementation of site Quality Management system, standards, and policies in alignment with iRhythm’s global quality management system
Collaborate closely with clinical operations supporting the development of procedures and ensuring appropriate execution within the quality management system
Act as Liaison with the iRhythm Independent Diagnostic Testing Facility (IDTF)
Collaborate closely with production and supply chain business partners to ensure a robust and fully compliant site Quality Management System
Establish and improve systems to monitor and improve site product quality and lead site quality improvement initiatives
Participate in, and/or lead/host site external audits such as FDA inspections and Notified Body audits
Represent area of responsibility in meetings with management
Contribute to efforts to maintain a positive quality culture, with operations fully acting as business partners, while advocating for patients and customers’ needs
Assume additional responsibilities and perform other duties as assigned

Skills

Quality Control

Reverse Logistics

Non-Conformance Investigations

Complaint Investigations

Calibration

MRB Processes

Inspection Readiness

Quality Metrics

Quality Management System

iRhythm Technologies

Advanced cardiac monitoring solutions provider

About iRhythm Technologies

iRhythm Technologies focuses on cardiac monitoring solutions, with its main product being the Zio Patch, a wearable device that tracks heart rhythms for up to 14 days. This extended monitoring helps healthcare providers detect irregular heart rhythms that shorter monitoring might miss, making it especially useful for patients at risk. The company serves both patients and healthcare providers, generating revenue by selling the Zio Patch and offering data analysis services to interpret the collected heart data. iRhythm aims to improve patient outcomes and streamline healthcare workflows in the cardiac health sector.

San Francisco, CaliforniaHeadquarters

2006Year Founded

$102.8MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

1,001-5,000Employees