Quality Operations Manager

About the position

iRhythm is currently seeking a Quality Operations Manager for its facility located in Deerfield, IL. The Quality Operations Manager will provide quality direction and tactical support to the reverse logistics intake operations, and the clinical operations teams. The role is responsible for all aspects of quality, compliance and execution of the site quality management system supporting intake operations and clinical operations. Our work environment is fast-paced, with a collaborative atmosphere. Most of all, we are passionate about delivering innovations that improve the quality of health care and the patient experience. We are looking for like-minded individuals to join our team today!

Responsibilities

• Oversee the management of the day-to-day site Quality Operations activities which include Quality Control, Reverse Logistics including intake operations, Product quality issues investigations, planned deviations and non-conformances, Complaint Investigations, as applicable, Calibration, 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 of operating within the quality management system.
• 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, 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.

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 working with regulatory directly with agencies such as FDA and EU Notified Bodies.
• Previous knowledge of regulations and standards such as ISO 13485, ISO14971, 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 with cross-functional partners.
• Demonstrated comfort working in a dynamic, entrepreneurial environment where strong organizational, leadership and communication skills are required to be successful.

Benefits

• Competitive salary package.
• Medical, dental and vision insurance.
• Paid holidays and paid time off.
• 401K (w/ company match).
• Employee Stock Purchase Plan.
• Annual organizational/cultural committee events.