Career-defining. Life-changing.
At iRhythm, you’ll have the opportunity to grow your skills and your career while impacting the lives of people around the world. iRhythm is shaping a future where everyone, everywhere can access the best possible cardiac health solutions. Every day, we collaborate, create, and constantly reimagine what’s possible. We think big and move fast, driven by our commitment to put patients first and improve lives. We need builders like you. Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career
About This Role:
As a Quality Manager, you will be responsible for the Quality System Document Management System and Training and own these processes across iRhythm sites. Your team will be responsible for the processing document changes, engineering change requests, retention policies and Quality Systems Training. In addition to managing the processes and team, you will be responsible for managing and enhancing the program and metrics.
In this role you will lead projects associated with global harmonization processes to ensure fully compliant and efficient document management and QMS training systems. This role reports directly to the Director of Quality Systems, with end-to-end ownership of Document Control, Training, and Change Management programs supporting regulated medical devices.
What You Will Be Doing
Quality Systems leader with robust experience managing Document Control, Change Management and Training functions within FDA-regulated medical device environment. Proven ability to scale document and training operations, lead high-performing teams, and partner cross-functionally to ensure inspection readiness, compliance, and operational efficiency. Deep expertise in 21 CFR 820, ISO 13485, EU MDR, and electronic QMS platforms. Trusted partner to Quality leadership, with a strong track record supporting remediation activities, audits, and enterprise-wide process improvements.
- 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
What We Want to See
- 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
iRhythm Technologies, Inc. is a publically 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.
Location:
Orange CountyActual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.
Estimated Pay Range
$123,000.00 - $160,000.00As a part of our core values, we ensure an 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 [email protected]
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.
There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process, or created postings for positions that do not exist. Please note that all open positions will always be shown here on the iRhythm Careers page, and all communications regarding the application, interview and hiring process will come from a @irhythmtech.com email address. Please check any communications to be sure they come directly from @irhythmtech.com email address. If you believe you have been the victim of an imposter or want to confirm that the person you are communicating with is legitimate, please contact [email protected]. Written offers of employment will be extended in a formal offer letter from an @irhythmtech.com email address ONLY.
For more information, see https://www.ftc.gov/business-guidance/blog/2023/01/taking-ploy-out-employment-scams and https://www.ic3.gov/Media/Y2020/PSA200121
