Global Quality Systems Manager, Documentation Systems at iRhythm

*this role can be located in San Francisco or Cypress, CA

About iRhythm:

iRhythm is a leading digital healthcare company focused on the way cardiac arrhythmia's are clinically diagnosed by combining our wearable bio sensing technology with powerful cloud-based data analytics and Artificial Intelligence capabilities. Our goal is to be the leading provider of ambulatory ECG monitoring for patients at risk for arrhythmia's. iRhythm’s continuous ambulatory monitoring has already put over 2 million patients and their doctors on a shorter path to what they both need – answers.

About this Role:

As a Quality Manager responsible for the Document Management System (DMS) and Training, you will own and lead these two processes across iRhythm sites.  Reporting to you will be a team responsible for the processing document changes, engineering change requests, and record retention policies.  In addition to the document control team, this manager will be responsible for managing and enhancing the Quality System training program and metrics.   

In this role you will lead projects associated with global process harmonization to ensure a fully compliant and efficient document management system, as well as, internal ownership of MasterControl, the e-QMS tool utilized at iRhythm.   

Responsibilities: 

• Maintain and improve processes associated with an electronic document control system within MasterControl.   
• Collaborate with partners at MasterControl, as well as, iRhythm’s IT team, in order to implement upgrades and ensure proper operation of the iRhythm e-QMS system.   
• Configure the DMS and Quality System Training processes to enhance compliance and efficiency in order to meet iRhythm’s growing needs.   
• Develop and maintain robust metrics and represent DMS and Training at Management Reviews. 
• Collaborate with Quality and Regulatory team members to create training content for Quality System procedures in order to enhance training effectiveness.       
• Represent the Quality dept. as the subject matter expert in good documentation practices, record retention regulations, and Quality System training.    
• Monitor team performance and provide coaching and development for the DMS and Training team members based on each individual’s development needs.     
• Ensure proper resourcing models are established for a growing company as it relates to document and record management.     
• Represent your team within internal and external audits including FDA inspections and Notified Body audits.     
• Perform other quality and regulatory-related duties as assigned 

Required Qualifications: 

• Bachelor’s Degree or equivalent experience  
• Minimum of 5 years of experience in Quality or Regulatory related role 
• Minimum of 2 years of experience in Document Management System   
• Minimum of 2 years of management experience   
• Must build rapport across functional teams within the organization  
• Attention to detail and timeliness are critical 
• Excellent communication (verbal and written) and interpersonal skills required  
• Ability to coach and train employees is critical   
• Must operate through collaboration and transparency  
• Must be a positive and energetic leader who is motivated to develop and grow a team 

What’s in it for you:

This is a full-time position with competitive compensation package and excellent benefits including medical, dental and vision insurance, paid holidays and paid time off.

iRhythm also provides additional benefits including 401K (w/ company match), employee stock purchase plan, annual organizational and cultural committee events and 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 (M/F/V/D). Pursuant to San Francisco Fair Chance Ordinance, we will consider for employment all qualified applicants with arrest and conviction records.

Make iRhythm your path forward.