About this Role:

iRhythm is currently seeking an experienced Senior Director, Quality Operations.  The Senior Director, Quality Operations will provide strategic direction and tactical operation to the quality teams supporting commercial operations, clinical operations, and supply chain including supplier management, manufacturing, distribution and logistics, reverse logistics and product intake across US and OUS sites. The role is responsible for all aspects of quality, compliance and execution of the quality management system supporting clinical operations and supply chain. 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!

Specific job responsibilities include:

• Lead a diverse global team of Quality Directors, Managers, and Engineers supporting commercial operations, clinical operations, and supply chain across the US and OUS sites.
• Represent quality with our iRhythm independent testing diagnostic facility (IDTF) operations
• Responsible for the execution of site inspection readiness programs, for sites under areas of responsibility.
• Define & Monitor Quality Operations, metrics to drive product and system quality improvements
• Develops policies and requirements for Quality operations that optimize compliance and decrease risk while maintaining an effective and efficient supply chain.
• Responsible for the success of achieving functional strategies and objectives
• Approves and directs the implementation of Quality System improvements, standards and policies in alignment with iRhythm’s global quality management system.      
• Collaborate closely with head of Quality System, Design Quality, and Operations to ensure a robust and fully compliant Quality Management System.
• Establish and improve systems to monitor and improve product quality and lead quality improvement initiatives.   
• Participate, and or lead/host external audits such as FDA inspections and Notified Body audits,
• Represent area of responsibility in meetings with executive management.
• Evaluates organizations capabilities against industry standards and regulatory expectations; applies technical, business and compliance knowledge to improve results.
• Responsible for hiring, coaching and counseling employees in a rapidly growing organization. Maintain a highly effective and engaged organization, with personnel who are appropriately skilled and motivated to contribute to the success of the company
• Contribute to efforts to maintain a positive quality culture, with a quality team that is fully acting as business partners, while advocating for patients and customers’ needs.
• Assume additional responsibilities and performs other duties as assigned.

About You: 

• Willing to work on site
• Bachelor's degree required in Science, Engineering, Computer Science, or related medical/science/healthcare field; or equivalent experience. 
• Minimum of 15 years of professional experience in quality and regulatory roles in the medical device field
• At least 10 years of experience in a management position with direct reports. 
• 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
• Demonstrated expert knowledge of regulations and standards such as ISO 13485, ISO14971, FDA 21 CFR 820, 806, 803, and EUMDR
• Previous experience leading organizations through regulatory compliance enforcement actions and challenges such as FDA warning letters.
• Direct experience leading and writing organizational responses to regulatory enforcement actions and audit findings.
• Direct experience with leading and hosting external regulatory and or third-party audits.
• Previous experience working and leading teams within a global environment
• High-level analytical skills and ability to focus on detail.
• Proven capacity to collaborate and build positive relationships and trust over time with cross-disciplinary audiences.
• Demonstrated comfort working in a dynamic, entrepreneurial environment where strong organizational, leadership and communication skills were required to be successful with a proven track record demonstrating the following skills:
• Influence without authority,
• Conflict resolution skills
• Organizational Management
• Analytical reasoning
• Change Management

What’s in it for you: 

This is a regular full-time position with competitive compensation package, excellent benefits including medical, dental, and vision insurances (all of which start on your first day), health savings account employer contributions (when enrolled in high deductible medical plan), cafeteria plan pre-taxed benefits (FSA, dependent care FSA, commute reimbursement accounts), travel reimbursement for medical care, noncontributory basic life insurance & short/ long term disability. Additionally, we offer:

• emotional health support for you and your loved ones
• legal / financial / identity theft/ pet and child referral assistance
• paid parental leave, paid holidays, travel assistance for personal trips and PTO!

iRhythm also provides additional benefits including 401(k) (with company match), an Employee Stock Purchase Plan, pet insurance discount, unlimited amount of LinkedIn Learning classes and so much more! 

FLSA Status: Exempt

As a part of our core values, we ensure a diverse and inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills, and perspectives. iRhythm Technologies, Inc. is an Equal Opportunity Employer. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws.

iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have any difficulty using our online system. If you need such an accommodation, you may contact us at taops@irhythmtech.com

About iRhythm Technologies
iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm’s vision is to deliver better data, better insights, and better health for all.

Make iRhythm your path forward. Zio, the heart monitor that changed the game.

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