Manager, QMS Document Management & Training

iRhythm•Orange County, CA

About The Position

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

Requirements

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

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