Document Control and Validation Specialist

Career-defining. Life-changing.

At iRhythm youll 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 whats 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:

TheDocument Control and Validation Specialist is responsible formanaging and implementing the process associated with creation and revision of iRhythms Marketing documents and develop and maintain validation documentation (test plans test scripts validation plan and reports).

Responsibilities:

• Responsible for coordination of controlled documents within iRhythms global Marketing system.
• Maintain and improve processesassociated with an electronic MLR system within the eQMS.
• Work cross-functionally to ensure change orders are executed in a complaint and timely manner.
• Responsible for the accuracy of documentation per approved Standard Operating Procedures GMP and internal change control.
• Supports internal and external audits in backrooms and helps with the coordination of document requests.
• Maintains quality records per applicable SOPs.
• Responsible for coordinating document change orders collaboration approval release archival and retention.
• Closely work with Training coordinator to ensure change orders are triggering training as required
• Develop and maintain validation documentation (test plans test scripts validation plan and reports)
• Support implementation of QMS systems dashboards or process changes through validation testing
• Design build and maintain dashboards and recurring reports
• Collaborate with cross-functional teams to understand reporting needs

Other duties may be assigned as deemed necessary by management

Responsibilities:

• Responsible for coordination of controlled documents within iRhythms global Marketing system.
• Maintain and improve processesassociated with an electronic MLR system within the eQMS.
• Work cross-functionally to ensure change orders are executed in a complaint and timely manner.
• Responsible for the accuracy of documentation per approved Standard Operating Procedures GMP and internal change control.
• Supports internal and external audits in backrooms and helps with the coordination of document requests.
• Maintains quality records per applicable SOPs.
• Responsible for coordinating document change orders collaboration approval release archival and retention.
• Closely work with Training coordinator to ensure change orders are triggering training as required
• Develop and maintain validation documentation (test plans test scripts validation plan and reports)
• Support implementation of QMS systems dashboards or process changes through validation testing
• Design build and maintain dashboards and recurring reports
• Collaborate with cross-functional teams to understand reporting needs
• Other duties may be assigned as deemed necessary by management

Required Qualifications:

• Must have strong communication (verbal and written) and interpersonal skills
• Attention to detail and timeliness are critical
• Strong attention to detail and data validation skills
• Computer Skills: software proficiency in Microsoft Office Suite is required
• Proficiency in Excel (advanced formulas pivot tables)
• Experience with BI tools (Tableau Power BI or similar)
• Strong attention to detail and data validation skills
• Previous Veeva experience is highly desirable
• Must build rapport acrossfunctional teams within the organization
• Bachelors Degreeor equivalent experience
• Minimum of 5years of experience in Document Management Systemor 2 years in Document Control and 3 years in applicable quality discipline
• Experience in reporting data analysis or business intelligence
• Understanding of the regulations and regulatory processes for document control/ management
• Must operate through collaboration and transparency
• Experience in cGMP/GDP/GCP environments and FDA-regulated industries is preferred
• Must be available to work during the hours to support the business needs (tentatively 8:00 pm-5:00 am)

Location:

As 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

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 iRhythms 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 @ email address. Please check any communications to be sure they come directly from @ 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 Written offers of employment will be extended in a formal offer letter from an @ email address ONLY.

For more information see and Experience:

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