iRhythm Technologies, Inc. · 1 day ago
Manager, QMS Document Management & Training
Orange County, CA
Full-time
Hybrid
Senior Level, Lead/Staff
$123K/yr - $160K/yr
12+ years expiRhythm Technologies, Inc. is a leading digital healthcare company focused on cardiac health solutions. The Quality Manager will oversee the Quality System Document Management and Training processes, ensuring compliance and operational efficiency across iRhythm sites.
Health CareHealth DiagnosticsMedical DevicemHealthWearables
Responsibilities
Own the full document lifecycle, including creation, review, approval, distribution, revision, archival, and obsolescence
Ensure controlled documentation complies with all required external and internal requirements
Partner with cross-functional teams to streamline documentation workflows and reduce cycle times
Responsible for change management
Support remediation activities, including document updates tied to CAPAs, audit findings, and regulatory commitments
Own and govern the Change Management / Change Control process, ensuring changes are assessed, approved, implemented, and verified in compliance with regulatory and quality requirements
Partner cross-functionally to ensure changes are risk-based, well-documented, and effectively communicated
Oversee the Training program to ensure role-based, timely, and compliant training across the global organization
Establish and maintain training matrices/curricula aligned to job functions and regulatory expectations
Drive continuous improvement in training effectiveness, including onboarding, recurring training, and inspection preparedness
Ensure accurate training records and audit-ready traceability
Collaborate with team members to create training content for Quality System procedures to enhance training effectiveness
Use data to drive proactive decision-making and resource planning
Lead or support cross-functional projects to improve usability, scalability, and compliance of quality systems
Work along with the eQMS team to configure the system to enhance compliance and efficiency to meet iRhythm’s growing global needs
Develop and maintain robust metrics and represent Document Control and Training at data reviews, including Management Review, highlighting trends, risks and improvement opportunities
Monitor team performance and provide coaching and development for the Doc Control, Records management, and Training processes team members based on each individual’s development needs
Responsible for recruiting (US and OUS) team members and the day-to-day operations of the Doc Control, Records management and Training processes
Define and execute a strategy for document and training compliance aligned with Quality Systems objectives and regulatory requirements
Represent the team within internal and external audits, including FDA inspections and Notified Body audits
Perform other quality and regulatory-related duties as assigned
Qualification
Required
Bachelor's Degree or equivalent experience
At least 12 years of experience in a quality-related role
At least 3 years of people management experience
Experience with FDA 21 CFR 820 / ISO 13485 / EU MDR
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
Benefits
Competitive compensation and benefits package
Company
iRhythm Technologies, Inc.
iRhythm is a leading digital health care company that creates trusted solutions that detect, predict, and prevent disease.
1001-5000 employees
H1B Sponsorship
iRhythm Technologies, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)
2024 (13)
2023 (10)
2022 (9)
2021 (16)
2020 (11)
Funding
Current Stage
Public CompanyTotal Funding
$1.18BKey Investors
BraidwellNovo HoldingsNorwest
2024-03-04Post Ipo Debt· $643.6M
2020-08-21Post Ipo Secondary· $220M
2019-09-11Post Ipo Equity· $115M
Leadership Team
Quentin Blackford
Chief Executive Officer
Mark Day
Chief Technology Officer
Recent News
2026-01-07
GlobeNewswire
2025-12-08
Company data provided by crunchbase