iRhythm Technologies, Inc. is a is a publicly held (Nasdaq: IRTC) medical device and healthcare information services company with a proven approach to long-term continuous monitoring that enables diagnosis earlier in the clinical pathway to improve patient outcomes and reduce healthcare costs. iRhythm provides competitive compensation and benefits package.
As the Global Quality Systems Manager responsible for the Document Management System (DMS, that includes Training Programs), you will own and lead quality system documentation, change control and training processes across all 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.
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
Role can be based in San Francisco or Cypress, CA
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
Internal Number: 1792
iRhythm is a leading digital healthcare company focused on the way cardiac arrhythmias 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 arrhythmias. 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